Prosthetic heart valve devices and associated systems and methods

ABSTRACT

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/807,788, filed Jul. 23, 2015, now allowed, which is acontinuation of U.S. patent application Ser. No. 13/949,098, filed Jul.23, 2013, now U.S. Pat. No. 9,125,740, which is a continuation ofInternational Application No. PCT/US2012/043636, filed Jun. 21, 2012,which claims priority to U.S. Provisional Patent Application No.61/499,632, filed Jun. 21, 2011, the disclosures of which areincorporated herein by reference in their entireties.

TECHNICAL FIELD

The present technology relates generally to prosthetic heart valvedevices. In particular, several embodiments are directed to heart valvedevices for percutaneous replacement of native heart valves andassociated systems and methods.

BACKGROUND

The present technology is generally directed to treatment of heartdisease related to valves of the heart such as percutaneous replacementof the mitral valve. Although specific reference is made to percutaneousreplacement of the mitral valve, embodiments of the present technologycan provide percutaneous or other treatment of other valves such as theaortic valve.

During a normal cycle of heart contraction (systole), when the leftventricle contracts, the mitral valve acts a check valve to prevent flowof oxygenated blood back into the left atrium. In this way, theoxygenated blood is pumped into the aorta through the aortic valve.Regurgitation of the mitral valve can significantly decrease the pumpingefficiency of the heart, placing the patient at risk of severe,progressive heart failure in at least some instances. The mitral valveregurgitation can be characterized by retrograde flow from the leftventricle of a heart through an incompetent mitral valve into the leftatrium.

Mitral valve regurgitation can result from a number of mechanicaldefects of the mitral valve. The mitral valve includes leaflets andchordae tendineae coupled to the leaflets. One or more of the leaflets,the chordae tendineae, or the papillary muscles may be damaged orotherwise dysfunctional. In at least some instances, the valve annulusmay be damaged, dilated, or weakened, thereby limiting the ability ofthe mitral valve to close adequately against the high pressures of theleft ventricle.

The prior methods and apparatuses to treat valves of the heart can beless than ideal in at least some instances. Although open heart surgerycan be used to repair valves of the heart, such surgery can be moreinvasive than would be ideal. For example, suturing opposed valveleaflets together, referred to as the “bow-tie” or “edge-to-edge”technique, can result in improved heart function. However, with openheart surgery the patient's chest is opened, typically via a sternotomy,and the patient on bypass can be traumatic and may have associatedmorbidity.

Although recent advances in percutaneous technologies have resulted invalve therapies that can be less invasive, such percutaneous therapiescan be less than ideal and may have less than ideal outcomes in at leastsome instances. Although clips may be delivered percutaneously toconnect leaflets of the mitral valve to perform an edge-to-edge repair,placement of these clips on the mitral valve can be difficult. Forexample, the mitral valve leaflets can move and change shape with bloodflow and contractions of the heart, such that alignment and placement ofa clip on the valve can be more difficult than would be ideal in atleast some instances. Further, many patients suffer from mitral valvedisease which is not treatable with such clips or other percutaneoustherapies so are left with no options other than open surgical repair ofreplacement.

Percutaneous treatment of the mitral valve can present additionalchallenges as compared with other valves such as the aortic valve. Themethods and apparatus appropriate for the aortic valve may not be wellsuited for use with the mitral valve in at least some instances. Themitral valve includes clusters of chordae tendineae extending from thevalve leaflets to the walls of the ventricle that may interfere withplacement of the prosthesis. The shape of the mitral valve, rather thanbeing circular and uniform like the aortic valve, can be an oval orkidney-shape that may not be well suited for supporting conventionalstents of cylindrical configuration. The mitral valve annulus can bedistorted and may have an unpredictable and non-uniform geometry, ascompared to the aortic valve annulus. Further, whereas the aortic valveannulus is often entirely surrounded by muscular tissue, the mitralvalve annulus may be bounded by muscular tissue on the outer wall only.The anterior side of the mitral valve annulus is bounded by a thinvessel wall. The thin vessel wall separates the mitral valve annulus andthe left ventricular outflow tract (“LVOT”), which must remain open toallow blood to pass into the aorta. As a result, the stent-type fixationupon which prior transcatheter prostheses rely may not be suitable forthe mitral valve because the anterior side of the valve has sufficientradial strength and can distort under the radial force of such a stent,risking occlusion of the left ventricular outflow tract. Moreover,mitral valve disease often is accompanied by (or caused by) gradualenlargement of the native annulus and/or the left ventricle. Thus,treatment approaches which rely upon radial engagement with or outwardcompression against the native annulus are subject to failure as thesize and shape of the annulus changes.

In light of the above, it would be desirable to provide improvedtreatments for heart valves, such as mitral valve replacement. Ideally,these treatments would decrease at least some of the deficiencies of theprior art, and provide improved percutaneous valve prostheses withgreater ease of alignment of improved coupling of the prostheses totissues of the heart.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent.

FIGS. 1 and 1A are schematic illustrations of a mammalian heart havingnative valve structures for replacement with various prosthetic heartvalve devices in accordance with embodiments of the present technology.

FIG. 1B is a schematic illustration of the left ventricle of a hearthaving prolapsed leaflets in the mitral valve, and which is suitable forcombination with various prosthetic heart valve devices in accordancewith embodiments of the present technology.

FIG. 1C is a schematic illustration of a heart in a patient sufferingfrom cardiomyopathy, and which is suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 1C-1 is a schematic illustration of a native mitral valve of aheart showing normal closure of native mitral valve leaflets.

FIG. 1C-2 is a schematic illustration of a native mitral valve of aheart showing abnormal closure of native mitral valve leaflets in adilated heart, and which is suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 1D illustrates mitral valve regurgitation in the left ventricle ofa heart having impaired papillary muscles, and which is suitable forcombination with various prosthetic heart valve devices in accordancewith embodiments of the present technology.

FIG. 1E is a schematic illustration of a mitral valve of a heart showingdimensions of the annulus, and which is suitable for combination withvarious prosthetic heart valve devices in accordance with embodiments ofthe present technology.

FIG. 1F is a schematic, cross-sectional illustration of the heartshowing an antegrade approach to the native mitral valve from the venousvasculature, in accordance with various embodiments of the presenttechnology.

FIG. 1G is a schematic, cross-sectional illustration of the heartshowing access through the interatrial septum (IAS) maintained by theplacement of a guide catheter over a guidewire, in accordance withvarious embodiments of the present technology.

FIGS. 1H and 1I are schematic, cross-sectional illustrations of theheart showing retrograde approaches to the native mitral valve throughthe aortic valve and arterial vasculature, in accordance with variousembodiments of the present technology.

FIG. 1J is a schematic, cross-sectional illustration of the heartshowing an approach to the native mitral valve using a trans-apicalpuncture, in accordance with various embodiments of the presenttechnology.

FIGS. 2A1 and 2A2 are side and top views of a prosthetic heart valvedevice having a valve portion, a support in a delivery configuration anda plurality of arms having an outward configuration configured to reachbehind leaflets of the native mitral valve, in accordance with anembodiment of the present technology.

FIG. 2A3 is a top view of the device of FIGS. 2A1 and 2A2 with thesupport in an expanded configuration and showing the valve open, inaccordance with an embodiment of the present technology.

FIG. 2A4 is a top view of the device of FIGS. 2A1 and 2A2 with thesupport in an expanded configuration and showing the valve closed, inaccordance with an embodiment of the present technology.

FIG. 2A5 is a side view of an individual arm in accordance with anembodiment of the present technology.

FIG. 2A6 is a schematic illustration showing a plurality of armsextending around a native leaflet and between chordae of a native mitralvalve, in accordance with an embodiment of the present technology.

FIGS. 2A7A-2A7D are side views of tip portions of individual arms, inaccordance with various embodiments of the present technology.

FIGS. 2A7E is a side view of a portion of a prosthetic heart valvedevice showing an arm having a curved tip portion oriented inwardlytoward the support for retaining a native leaflet around the proximalend of the support, in accordance with an embodiment of the presenttechnology.

FIG. 2A8 is a top view of a prosthetic heart valve device showing asupport and a plurality of arms, wherein the arms are in an inwardconfiguration and wherein pressure reducing tip portions of the arms areoriented along a surface of the support, in accordance with anembodiment of the present technology.

FIG. 2A9 is a side view of a prosthetic heart valve device showing armsin an outward configuration at varying splay angles from a supportconfigured in accordance with an embodiment of the present technology.

FIGS. 2A10 and 2A11 are top and side views, respectively, of a supportand a plurality of arms arranged in varying splay angles relative to alongitudinal axis of the support configured in accordance with anembodiment of the present technology.

FIG. 2B-1 is a schematic, cross-sectional illustration of a heartshowing delivery of a prosthetic heart valve device positioned in adistal end of a delivery catheter to the native mitral valve MV regions,in accordance with various embodiments of the present technology.

FIG. 2B-2 is an enlarged cross-sectional view of a prosthetic heartvalve device within a catheter sheath for delivering to a native valveregion of the heart configured in accordance with an embodiment of thepresent technology.

FIG. 2C is an isometric side view of the prosthetic heart valve deviceof FIG. 2B-A having the catheter sheath retracted from the plurality ofarms and showing the plurality of arms extending outward from thesupport for positioning at the native valve structure and configured inaccordance with an embodiment of the present technology.

FIG. 2C1 is a top view of the device shown in FIG. 2C.

FIG. 2C2 is a side view of an individual arm configured to have variablelength and in accordance with another embodiment of the presenttechnology.

FIGS. 2C3 and 2C4 are side views of individual arms showing,respectively, a first outward configuration prior to expansion of thesupport and a second outward configuration after expansion of thesupport configured in accordance with an embodiment of the presenttechnology.

FIGS. 2C5 and 2C6 are side views of individual arms showingschematically a twisting movement of the arms when transitioning fromthe first outward configuration (FIG. 2C5) to the second outwardconfiguration (FIG. 2C6), in accordance with an embodiment of thepresent technology.

FIG. 2D is a schematic illustration showing a view from above of aprosthetic heart valve having a plurality of arms positioned behindcentral portions of the native valve leaflets in accordance with variousaspects of the present technology.

FIGS. 2E and 2F are side and top views, respectively, of a prostheticheart valve device positioned within a native valve and showing asupport in an expanded configuration and a plurality of arms extendingoutward from the support to reach behind native leaflets and engage asubannular region of the native annulus in accordance with variousaspects of the present technology.

FIGS. 2F1-A and 2F1-B are side and top views, respectively, of aprosthetic heart valve device having sealing members configured to bepositioned adjacent the commissures of the native valve, and inaccordance with another embodiment of the present technology.

FIGS. 2F2-A and 2F2-B are isometric side and top views, respectively, ofa prosthetic heart valve device having a bell-shaped skirt tapering froman open downstream end to a closed, narrower upstream end configured inaccordance with a further embodiment of the present technology.

FIGS. 2F3A-2F3B and 2F4A-2F4C are side views of a prosthetic heart valvedevice having alternative skirt configurations in accordance withfurther embodiments of the present technology.

FIGS. 2F5A and 2F5B are top and cross-sectional side views,respectively, of a prosthetic heart valve device having leaflet pushersshown in an open or separated configuration and in accordance with anembodiment of the present technology.

FIGS. 2F5C and 2F5D are top and cross-sectional side views,respectively, of a prosthetic heart valve device having leaflet pushersshown in a closed or inward configuration in accordance with anembodiment of the present technology.

FIG. 2G is a schematic illustration of a side view of a prosthetic heartvalve device having a support shown in an extended configuration and aplurality of arms extending between chordae tendineae, in accordancewith various embodiments of the present technology.

FIG. 2H-1 is an isometric side view of a prosthetic heart valve devicehaving a flange extending outwardly from the support at a proximal,upstream end configured in accordance with another embodiment of thepresent technology.

FIG. 2H-2 is an isometric view of a prosthetic heart valve device havinga support and a plurality of elongated fingers extending radiallyoutward from the proximal, upstream end of the support configured inaccordance with a further embodiment of the present technology.

FIG. 2I is an isometric side view of a prosthetic heart valve deviceconfigured for positioning in a native aortic valve, and in accordancewith another embodiment of the present technology.

FIG. 2J is a top view of a prosthetic heart valve device having aplurality of sealing members configured to extend toward tricuspid valvecommissures of the native aortic valve, and in accordance with yetanother embodiment of the present technology.

FIG. 3A is an isometric view of a prosthetic heart valve device having aexpandable support shown in a delivery configuration and having aplurality of arms shown in an inward configuration, such that the deviceis suitable to access a valve of the body percutaneously, and inaccordance with various embodiments of the present technology.

FIGS. 3B, 3C and 3D show front, side, and top views, respectively, ofthe device having the expandable support and plurality of armsconfigured as in FIG. 3A.

FIG. 3E is an isometric view of a prosthetic heart valve device havingan expandable support shown in the delivery configuration and aplurality of arms shown in an outward configuration such that the armsare positioned to receive leaflets of a native valve between the armsand the expandable support, and configured in accordance with a furtherembodiment of the present technology.

FIGS. 3F, 3G and 3H show front, side, and top views, respectively, ofthe device having the expandable support and plurality of armsconfigured as in FIG. 3E.

FIG. 3I is an isometric view of a prosthetic heart valve device havingan expandable support shown in an expanded configuration and a pluralityof arms shown in the outward configuration such that the device issuitable to couple to the annulus of a native valve, configured inaccordance with additional embodiments of the present technology.

FIG. 3I1 is a force diagram illustrating the forces exerted on the armsduring systole and showing the corresponding forces to the support'sstruts and posts in accordance with aspects of the present technology.

FIGS. 3J, 3K and 3L show front, side, and top views, respectively, ofthe device having the expandable support and plurality of armsconfigured as in FIG. 3I.

FIGS. 4A and 4B are side views of prosthetic heart valve devices havinga plurality of arms shown a first inward configuration (FIG. 4A) and anoutward configuration and having a plurality of lengths (FIG. 4B),configured in accordance with other embodiments of the presenttechnology.

FIGS. 5A1 to 5A4 are side views of a prosthetic heart valve devicehaving arms with ringed ends configured in accordance with an embodimentof the present technology.

FIG. 5A5 is a partial side view of a prosthetic heart valve devicehaving arms with a first, flattened cross-sectional dimension and asecond, elongated cross-sectional dimension such that the arms have arelative resistance to bending in different directions and configured inaccordance with an embodiment of the present technology.

FIG. 5A6A shows a portion of the arm along line A-A of FIG. 5A5.

FIG. 5A6B shows a portion of the arm along line B-B of FIG. 5A5.

FIGS. 5A7-5A8 are side and front views, respectively, of prostheticheart valve devices with arms including arm tips having a bent tipportion for providing a planar subannular interfacing tip configured inaccordance with embodiments of the present technology.

FIGS. 5A9-5A10 are partial side views of a prosthetic heart valve devicehaving an arm with loop and two support attachment points. The loopedarm can be in an outward configuration (FIG. 5A9) suitable forpositioning within a native valve structure, or in an inwardconfiguration (FIG. 5A10) with a low cross-sectional profile suitablefor retention in a delivery catheter and configured in accordance withan embodiment of the present technology.

FIG. 5A11 is a perspective view of a further embodiment of a prostheticheart valve device having a cover thereon in accordance with aspects ofthe present technology.

FIGS. 5A12-5A15 are partial side views showing various embodiments ofcovers on arms of a prosthetic heart valve device in accordance withaspects of the present technology.

FIGS. 6A1 to 6B4 are bottom, front, side and isometric views ofprosthetic heart valve devices showing arms that cross from a supportattachment site on a first side of a support to a leaflet and/or annulusengaging site oriented on a second side of the support opposite thefirst side and configured in accordance with additional embodiments ofthe present technology.

FIG. 7A is a top view of a prosthetic heart valve device having anexpanded support with arms and a separate prosthetic valve retained andpositioned inside the expanded support configured in accordance with anembodiment of the present technology.

FIG. 7A1 is a perspective view of a separate prosthetic valve shown inan expanded configuration and configured for use with an expandedsupport of a prosthetic heart valve device configured in accordance withan embodiment of the present technology.

FIG. 7B is a top view of a prosthetic heart valve device having anexpanded support with arms and a temporary valve structure, and showinga separate prosthetic valve retained and positioned inside the expandedsupport and within the temporary valve structure and configured inaccordance with another embodiment of the present technology.

FIGS. 7B1 to 7B3 show various components and construction of a temporaryvalve comprising leaflets, in accordance with embodiments of the presenttechnology.

FIG. 7C is a top view of a prosthetic hear valve device having anexpandable support with a plurality of arms and a temporary valvemounted within the expandable support configured in accordance with anembodiment of the present technology.

FIGS. 8A-8C are enlarged cross-sectional views of a delivery cathetercomprising an inner shaft, a tubular middle shaft slidable over theinner shaft, and a sheath configured to slide over the middle shaft andconfigured in accordance with embodiments of the present technology.

FIGS. 9A-9D are enlarged cross-sectional views of a delivery catheterhaving an inner shaft and a middle shaft, in accordance with additionalembodiments of the present technology.

FIG. 10 is an enlarged cross-sectional view of a delivery catheterincluding a second sheath slidably disposed within a first sheath, inwhich the second sheath is configured to slide between the outer surfaceof a support and a plurality of arms of a prosthetic heart valve deviceand configured in accordance with a further embodiment of the presenttechnology.

FIGS. 11A-11C are side cross-sectional views of a distal portion of adelivery system for a prosthetic heart valve device configured inaccordance with another embodiment of the present technology.

FIGS. 12A-12C are side elevational views of various components of adelivery system for a prosthetic heart valve device configured inaccordance with additional embodiments of the present technology.

FIGS. 12D-12G are side views of a distal portion of the delivery systemof FIGS. 12A-12C having a prosthetic heart valve device disposed thereinand showing various arrangements of the device during deployment of thedevice from the delivery system, in accordance with an embodiment of thepresent technology.

FIGS. 13A-13B are elevated side and oblique views, respectively, of aprosthetic heart valve device having a belt coupled between anexpandable support and a plurality of arms configured in accordance withan embodiment of the present technology.

FIGS. 13C-13D are top views of the device of FIGS. 13A-13B showing thearms in an outward orientation (FIG. 13C) and in an inward orientationor configurations (FIG. 13D) in accordance with aspects of the presenttechnology.

FIG. 14 is an elevated side view of a prosthetic heart valve devicehaving a pair of belts coupled between an expandable support and aplurality of arms configured in accordance with another embodiment ofthe present technology.

FIGS. 15A-15C are side views of a portion of an individual armassociated with a prosthetic heart valve device and showing mechanismsfor coupling a belt to the arm in accordance with various embodiments ofthe present technology.

FIGS. 16A-16C are oblique views showing the making of an arm for aprosthetic heart valve device wherein the arm has an eyelet to receive abelt and configured in accordance with further embodiments of thepresent technology.

DETAILED DESCRIPTION

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1-16C. Although many of the embodimentsare described below with respect to devices, systems, and methods forpercutaneous replacement of a native heart valve using prosthetic valvedevices, other applications and other embodiments in addition to thosedescribed herein are within the scope of the technology. Additionally,several other embodiments of the technology can have differentconfigurations, components, or procedures than those described herein. Aperson of ordinary skill in the art, therefore, will accordinglyunderstand that the technology can have other embodiments withadditional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1-16C.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculator (e.g., the end of the catheter). With respect to a prostheticheart valve device, the terms “proximal” or “distal” can refer to thelocation of portions of the device with respect to the direction ofblood flow. For example, proximal can refer to an upstream position or aposition of blood inflow, and distal can refer to a downstream positionor a position of blood outflow. For ease of reference, throughout thisdisclosure identical reference numbers and/or letters are used toidentify similar or analogous components or features, but the use of thesame reference number does not imply that the parts should be construedto be identical. Indeed, in many examples described herein, theidentically numbered parts are distinct in structure and/or function.The headings provided herein are for convenience only.

Overview

Systems, devices and methods are provided herein for percutaneousreplacement of native heart valves, such as mitral valves. Several ofthe details set forth below are provided to describe the followingexamples and methods in a manner sufficient to enable a person skilledin the relevant art to practice, make and use them. Several of thedetails and advantages described below, however, may not be necessary topractice certain examples, and methods of the technology. Additionally,the technology may include other examples and methods that are withinthe scope of the claims but are not described in detail.

Embodiments of the present technology provide systems, methods andapparatus to treat valves of the body, such as heart valves includingthe mitral valve. The apparatus and methods enable a percutaneousapproach using a catheter delivered intravascularly through a vein orartery into the heart. Additionally, the apparatus and methods enableother less-invasive approaches including trans-apical, trans-atrial, anddirect aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. The apparatus and methods enable a prostheticdevice to be anchored at a native valve location by engagement with asubannular surface of the valve annulus and/or valve leaflets. Inaccordance with various embodiments of the present technology, the valveannulus or leaflets are engaged within a subannular space behind(radially outside of) the native leaflets. In particular embodiments,the subannular surface is engaged by one or more elongated members, orarms, which extend from a location downstream of the native annulus. Theelongated members may extend around a downstream edge of at least onenative leaflet, and may further pass between two or more chordaetendineae coupled to the native leaflets. The elongated members may havean upstream end configured to engage the subannular surface. In someembodiments, the elongated members are oriented so as to be generallyorthogonal to, or at an oblique angle between about 45 and 135 degreesrelative to, the subannular surface, such that the loading exerted uponthe elongated members is primarily a compressive, axial load. Theprosthetic device may comprise a support coupled to the elongatedmembers which contains a prosthetic valve, or which is configured toreceive a separately-delivered prosthetic calve, such as a stented valveprosthesis. The elongated members can be configured to maintain theposition of the prosthetic device and resist movement in at least theupstream direction when the device is subject to the force of bloodpressure downstream of the valve and when the valve is closed.

In some embodiments, the arms of the apparatus may be shorter in lengthso as to not extend completely into engagement with the annulus tissuebehind the leaflets. Additionally, in some arrangement, the arms maycomprise short hooks which extend around the free edges of the nativeleaflets and behind the leaflets only a short distance sufficient tokeep the arms from slipping off the leaflets. The arms may alternativelybe configured to engage or couple to the chordae, papillary muscles orventricular walls to enhance anchoring. Moreover, the arms may beconfigured to remain on the inner sides of the native leaflets and toengage the leaflets themselves, or to penetrate through the leaflets tocontact the annulus or other tissue behind the leaflets. All of thevarious features and characteristics of the arms described herein may beapplicable to longer arms, which engage sub-annular tissue, as well asshorter arms or arms which remain on the inner sides of the leaflets.Additionally, devices may include or incorporate a plurality of arms ofdifferent length or arms having different modes of engagement with theleaflets or other native tissue.

The devices, systems and methods described herein overcome many of thechallenges of previous percutaneous valve replacement approaches. Inparticular, the apparatus and methods may eliminate the need to relysolely upon radial engagement with an outward force against the nativevalve annulus in order to anchor the prosthetic device, such as areplacement valve, to the native valve. The apparatus and methods may bewell-suited for treating non-circular, asymmetrically shaped valves andbileaflet or bicuspid valves, such as the mitral valve. The apparatusand methods further provide for permanent and reliable anchoring of theprosthetic device even in conditions where the heart or native valve mayexperience gradual enlargement or distortion.

Some embodiments of the disclosure are directed to prosthetic heartvalve devices for implanting at a native valve located between an atriumand a ventricle of a heart of a patient. Such devices are suitable, forexample, for implantation at native valves that have an annulus andleaflets coupled to the annulus. In one embodiment, the device can havean expandable support having an outer surface and configured forplacement between the leaflets. The device can also have a plurality ofarms coupled to or otherwise extending from the expandable support andconfigured to receive the leaflets between the arms and the outersurface of the expandable support. In some embodiments, at least twoarms can have different lengths to extend different distances behind theleaflets to engage a subannular surface of the annulus. In otherembodiments, the plurality of arms can be asymmetrically arranged arounda circumference of the expandable support and configured to receive theleaflets between the arms and the outer surface. In some examples,asymmetrically arranged arms can be arms with varying distance betweenadjacent arms. Alternatively or additionally, the arms may beasymmetrically arranged around a longitudinal axis passing through acenter of the expandable support, e.g., with more arms disposed on oneside of the axis than on an opposite side. In other examples,asymmetrically arranged arms can be arms having varying lengths orvarying extension angles, wherein an extension angle is the anglebetween an upstream extending portion of the arm and the vertical orlongitudinal axis of the support. In further examples, asymmetricallyarranged arms can be arms having varying splay angles for increasing ordecreasing the distance between tip portions of adjacent arms. A personskilled in the art will recognize other ways to asymmetrically arrangearms around the circumference of the expandable support.

In another embodiment, the device can further include a sealing membercoupled to at least one of the expandable support and the arms. Thesealing member, in some embodiments can be membranes configured toextend from the expandable support into the commissural region of thevalve as to inhibit blood flow through a commissural region of a valve.In some embodiments, the device can include two sealing members, whichcould be membrane structures or rigid structures) oriented on the deviceto inhibit blood flow through commissural regions of a bicuspid valve(e.g., mitral valve or a bicuspid aortic valve). In another embodiment,the device can include three or more sealing embers oriented on thedevice as to inhibit blood flow through commissural regions of atricuspid (e.g., aortic valve) or other valve. In a further embodiment,the device can include a single skirt shaped membrane oriented on thedevice as to inhibit blood flow through gaps formed between the deviceand the native valve.

Other embodiments of the disclosure are directed to prosthetic heartvalve devices for implantation at a native valve region of a heart. Inone embodiment, the device can include an expandable support having anupstream portion and a downstream portion. The expandable support canalso be configured to be located at the native valve region such thatthe upstream portion is in fluid communication with a first heartchamber and the downstream portion is in fluid communication with asecond heart chamber or portion. In one example, the native valve regioncan be a mitral valve region and the first heart chamber can be a leftatrium and the second hart chamber can be a left ventricle. In anotherexample, the native valve region can be an aortic valve region and thefirst heart chamber can be a left ventricle and the second heart chamberor portion can be an aorta.

The prosthetic heart valve device can also include a plurality of armscoupled to the expandable support at the downstream portion. The arms,for example, can be formed integrally with the expandable support, orthe arms can be separate components that are attached to the expandablesupport (e.g., spot welded). In one embodiment, each individual arm canbe configured to extend from the downstream portion to engage asubannular surface of the native valve region within the second chamber(or portion). In some embodiments, at least some of the individual armshave independently adjustable lengths. In other embodiments, theindividual arms can have a base portion, an extension portion and anelbow portion connecting the base portion to the extension portion. Theextension portion can be configured, in some embodiments, to engage asubannular surface of the native valve region within the second chamberor portion. In further embodiments, individual arms extend from thesupport at different splay angles.

Further embodiments of the present technology provide a device to treata heart valve of a patient, wherein the valve includes an annulus andleaflets coupled to the annulus. The device can include an expandablesupport comprising an outer surface, an upstream portion and adownstream portion. The support can be configured for placement betweenthe leaflets. The device can also include a plurality of arms coupled tothe expandable support. In some arrangements, the plurality of arms caninclude a first plurality of arms and a second plurality of arms. Thefirst plurality of arms can be arranged on a first portion of thesupport to receive a first leaflet and the second plurality of arms canbe arranged on a second portion of the support to receive a secondleaflet. In some examples, the first plurality of arms can include alarger number of arms than the second plurality of arms.

Another embodiment of the present technology provides a device forrepair or replacement of bicuspid heart valve having an annulus,leaflets coupled to the annulus and chordae tendineae coupled to theleaflets. The device can include a hollow support positionable betweenthe leaflets and having an interior to which a valve may be coupled. Thedevice can also include an anchoring portion coupled to the support. Theanchoring portion can have an arcuate region configured to extend arounda downstream edge of at least one leaflet, an extension regionconfigured to extend from the downstream edge between the chordaetendineae to the annulus, and an engagement region configured to engagea subannular surface of the annulus so as to inhibit movement of thedevice in a upstream direction. The device can also optionally include asealing member coupled to at least one of the support and the anchoringportion and extending downwardly from the expandable support into acommissural region of the bicuspid valve so as to occlude thecommissural region to inhibit blood flow through the commissural region.In some embodiments, the membrane can be a sealing member configured toengage the commissural region from a ventricle or downstream side of thebicuspid heart valve.

Further embodiments of the disclosure are directed to devices for repairor replacement of a heart valve having an annulus and leaflets coupledto the annulus. In one embodiment, the device can include a cylindricalsupport configured for placement between the leaflets. The support caninclude proximal and distal portions, or in other embodiments, upstreamand downstream portions. The cylindrical support can also include aninterior in which a valve may be coupled. The device can also include afirst group of arms (e.g., anchoring arms) coupled to a posterior sideof the cylindrical support and a second group of arms (e.g., anchoringarms) coupled to an anterior side of the cylindrical support oppositethe posterior side. In one embodiment, each arm can be configured toextend around a downstream edge of a leaflet and extend between thechordae tendineae. Each arm may also engage a subannular surface of theannulus so as to inhibit movement of the support in an upstreamdirection. In some arrangements, the first group of arms can beconfigured to engage a first subannular surface along a first line andthe second group of arms can be configured to engage a second subannularsurface along a second line. In some embodiment, the first and secondlines can be non-parallel to the annulus. For example, in oneembodiment, the first and second lines are substantially straight, andin another embodiment, the first and second lines can have a curvaturesubstantially larger than a radius of the annulus.

In some embodiments, anchoring means can be coupled to downstreamportions of the cylindrical support and extend outwardly in an upstreamdirection. The anchoring arms can have distal tips configured toatraumatically engage the annulus of the heart valve. In somearrangements, the plurality of anchoring arms can include a first andsecond plurality of anchoring arms. The first plurality of anchoringarms can have a characteristic different than the second plurality ofanchoring arms. Examples of such arm characteristics can include size,shape, stiffness, splay angle, spacing from the support, and the numberof arms disposed within a given area of the support. One or ordinaryskill in the art will recognize other arm characteristics that can varybetween separate groups of arms coupled to the support and/or associatedwith the devices disclosed herein.

In a further embodiment, the cylindrical support can have upstream anddownstream ends, an interior in which a valve may be coupled, and aperimeter. A plurality of arms can be coupled to the cylindrical supportand extend outwardly and in an upstream direction. The arms can includedistal tips configured to atraumatically engage the annulus of the heartvalve. Further, the arms can be unevenly or otherwise irregularlydistributed about the perimeter such that at least a first adjacent pairof arms is spaced closer together than at least a second adjacent pairof arms.

Other embodiments of the disclosure are directed to prosthetic heartvalve devices having cylindrical supports having upstream and downstreamends, an interior in which a valve may be coupled and a centrallongitudinal axis. The devices can also include a plurality of armsextending outwardly from the cylindrical support in an upstreamdirection. The arms can have distal tips configured to atraumaticallyengage a subannular surface of a native heart valve. In someembodiments, at least one of the arms can extend outwardly from thelongitudinal axis by a greater distance than at least a second of thearms.

A prosthetic heart valve device may also, in some embodiments, includean expandable support having an upstream portion and a downstreamportion. The support, for example, can be configured to be located at anative valve region such that the upstream portion is in fluidcommunication with a first heart chamber and the downstream portion isin fluid communication with a second heart chamber. The device can alsoinclude at least one arm coupled to the support and extending in anupstream direction with a distal tip configured to engage an annulus ofthe native valve region within the second heart chamber. The arm canhave a column strength selected to maintain the position of the supportrelative to the heart valve under the force of blood during systole,e.g., a force of at least about 0.5 lbf exerted against the support inthe upstream direction. If multiple arms are utilized, the columnstrength of each arm can be selected such that in combination the armsmaintain the position of the support relative to the heart valve undersuch a systolic load.

Some devices can include a cylindrical support having a longitudinalaxis and an interior along the longitudinal axis through which blood mayflow. The device may also include a valve coupled within the interior ofthe support that is configured to block blood flow through the supportin an upstream direction and allow blood flow through the support in adownstream direction. The device can further include a plurality of armscoupled to the support and extending in the upstream direction along anexterior wall or surface of the support. The device may be movable intoa plurality of configurations that can include a) a first configurationin which the support is radially contracted and each arm is in an inwardposition against or adjacent to the exterior wall of the support, b) asecond configuration in which the support is radially contracted andeach arm is in an outward position spatially separated from the exteriorwall by a distance sufficient to receive a leaflet of the heart valvetherebetween, and c) a third configuration in which the support isradially expanded and each arm is positioned closer to the exterior wallof the support than in the second configuration.

In many embodiments, an apparatus comprises an expandable supportcoupled to a plurality of arms. The expandable support may comprise anupstream portion for placement near an upstream portion of the valve anda downstream portion for placement near a downstream portion of thevalve. The plurality of arms may extend from the downstream portion andmay comprise an inward configuration for placement in a lumen of acatheter and an outward configuration to reach behind the leaflets andengage the annulus. The expandable support and the plurality of arms canbe introduced into the patient percutaneously with the plurality of armscomprising the inward configuration and the expandable supportcomprising a first non-expanded configuration, such that the support andthe plurality of arms can be advanced along the lumen of a cathetertoward the intended valve. A sheath covering the plurality of arms andthe expandable support can be drawn proximally so as to expose theplurality of arms, and the plurality of arms can move outward from theexpandable support so as to comprise the outward configuration. In theoutward configuration, the plurality of arms can extend, in someembodiments, between chordae tendineae of the mitral valve and receivethe leaflets between the plurality of arms and the support. The supportcan be moved upstream with the leaflets received between the pluralityof arms and the support so as to guide the plurality of arms toward theannulus. When the support has moved upstream a sufficient distance, theplurality of arms can engage the annulus with the leaflets extendingsubstantially between the plurality of arms and the support such thatthe plurality of arms can engage the annulus with direct contract andwith decreased interference of the leaflets. The expandable support canbe expanded to an expanded configuration when the plurality of armsengages the annulus in the outward configuration. The arms may havesufficient flexibility to deflect inwardly and outwardly relative to thesupport sufficiently to accommodate any expansion or distortion of thenative annulus which may occur in a heart afflicted with mitral valvedisease, congestive heart failure, or other conditions.

A valve can be provided which is configured to be coupled to the supportwhen the support is in the expanded configuration. The valve may bedelivered separately from the support and coupled to the support afterthe support has been implanted at the native valve site. Alternativelythe valve may be pre-mounted to the support and delivered with it to thetarget site. The valve may also be a temporary valve which regulatesblood flow through the support for a temporary period, e.g. 15 minutesto 3 days, until a permanent prosthetic valve is delivered and coupledto the support. The valve can be supported with the plurality of armsengaging the ventricular side of the annulus behind the leaflets withthe arms in the outward configuration, such that the valve is supportedby direct coupling to the native annulus. This engagement of the annulusby the plurality of arms can provide safe and reliable coupling to thenative valve. The integrity of neighboring tissues and structures can besubstantially maintained and blood flow through the aortic outflow tractcan be substantially unimpeded. The arms may comprise sufficientstrength to support the valve and maintain its position during systole,and the strength may comprise a column strength which keeps the armsfrom buckling or fracturing under the force of blood against the valvecoupled to the support.

The plurality of arms may comprise one or more structures to couple tothe annulus of the valve. Each of the plurality of arms may comprise atip portion to inhibit penetration of the annulus. The tip portion maycomprise a cross-sectional size to inhibit excessive penetration of theannulus. The plurality of arms may comprise a portion to providedeflection of the tip portion.

Each of the plurality of arms may comprise a mechanism to vary thelength of the arm, such as a telescopic component. The mechanism maycomprise a locking mechanism which locks when the plurality of armsengage the annulus. Alternatively or in combination, the plurality ofarms can be shaped to engage the annulus of the mitral valve. A firstplurality of arms can be configured to engage a first portion of theannulus on a first side of the support and a second plurality of armscan be configured to engage a second portion of the annulus on a secondside of the support. Each of the first plurality of arms and the secondplurality of arms may be splayed outwardly from a surface of the supportand configured to pass between chordae coupled to the leaflets withminimal interference therewith.

In many embodiments, the support can be configured to receive anexpandable valve when the support is in the expanded configuration. Theexpandable valve may comprise an expandable stented valve, and thesupport may comprise retaining structures to couple to the expandablestented valve with one or more of friction, compression, or interlockingelements. In some embodiments, the expandable support is configured toreceive an expandable aortic stented valve when the support is placed inthe mitral valve. The support may be disposed in the expandedconfiguration when coupled to the expandable aortic stented valve andconfigured such that the support and the plurality of arms substantiallymaintain the shape and size of the native annulus and do not extendexcessively into the aortic outflow tract so that blood flow through theaortic outflow tract is substantially unimpeded.

Certain embodiments of the present technology provide an apparatus totreat a mitral valve located between an atrium and a ventricle of aheart of a patient. The mitral valve has an annulus, leaflets coupled tothe annulus, and chordae tendineae coupled to the leaflets. Theapparatus comprises an expandable support comprising an outer surface.The expandable support is configured for placement between the leafletsand comprises an upstream portion and a downstream portion. A pluralityof arms is coupled to the expandable support. The plurality of arms isconfigured to receive the leaflets between the arms and the outersurface and extend behind the leaflets so as to engage the annulus.

In many embodiments, the plurality of arms is configured to engage theannulus so as to inhibit movement of the support toward the atrium. Theplurality of arms collectively may have column strength sufficient tosupport a systolic load of at least about 2 to 5 lbf exerted in theaxial direction on the support. In some embodiments, each arm may beconfigured to support an axial compressive load of at least about 0.2lbf, and in other embodiments, at least about 0.5 lbf.

In many embodiments, a valve is coupled to the support and is configuredto inhibit retrograde blood flow when the left ventricle of the heartcontracts, and the plurality of arms extends from the support to theannulus so as to couple the valve to the annulus.

In many embodiments, the plurality of arms is configured to contact theleaflets so as to further resist movement of the support. Each of theplurality of arms can be separated from the outer surface by a gapdistance sized to receive the leaflets such that the leaflets arereceived between the plurality of arms and the support. The gap distanceassociated with each of the plurality of arms can be sized to guide theplurality of arms toward the annulus. Each of the plurality of arms canbe independently deflectable to vary the gap distance if engaged bytissue during positioning. The arms may further be configured to bemovable from a first position having a first gap distance to a secondposition having a second gap distance, the first gap distance beinglarger than the second gap distance. The arms may be moved automaticallyfrom the first position to the second position when the support isexpanded to the expanded configuration, or the arms may be activelymovable on demand either before or after the support is expanded. Thearms may further be movable to a third position have a gap distance evensmaller than in the first or second positions, in which the arms have aminimal profile so as to facilitate endovascular delivery to the targetsite. The arms may have an unbiased configuration which corresponds toeither the first, second, or third positions.

In another aspect, embodiments of the present technology provide amethod of treating a mitral valve of a patient, in which the mitralvalve has an annulus and leaflets. The method comprises placing anapparatus comprising an expandable support coupled to a plurality ofarms along the mitral valve such that the plurality of arms engages theannulus behind the leaflets.

In a further aspect, embodiments of the present technology provide asystem to treat a mitral valve of a patient, in which the mitral valvehas an annulus. The system comprises an apparatus to treat the mitralvalve as described herein and a catheter having the apparatus within alumen of the catheter.

In yet another aspect, embodiments of the present technology provide amethod of treating a valve of heart of a patient. The valve has anannulus and leaflets. The method can include implanting a device asdescribed herein within or adjacent to the annulus. The device, in someembodiments, can include an expandable support coupled to a plurality ofarms. The support can be disposed between the leaflets and the pluralityof arms can be configured to engage the annulus behind the leaflets.Accordingly, the method can also include engaging a surface of theannulus behind the leaflets by a plurality of arms coupled to theexpandable support so as to inhibit movement of the support, and, insome embodiments, include coupling a valve to the support to allow bloodflow in a first direction through the support and inhibit blood flow ina second direction through the support.

In another aspect, embodiments of the present technology provide anapparatus to treat a valve of a patient, in which the valve comprises anannulus and leaflets coupled to the annulus. An expandable supportcomprises an outer surface, and the expandable support is configured forplacement between the leaflets. The expandable support comprises anupstream portion and a downstream portion when placed between theleaflets. A plurality of arms is coupled to the expandable support andextends from the downstream portion. The plurality of arms comprises afirst plurality of arms and a second plurality of arms. The firstplurality of arms is arranged on a first portion of the support toreceive a first leaflet, and the second plurality of arms is arranged ona second portion of the support to receive a second leaflet. At leastsome of the first and second plurality of arms engage the annulus behindthe first and second leaflets so as to inhibit movement of the support.A temporary or permanent valve may be coupled to the support to allowblood flow in a first direction and inhibit blood flow in a seconddirection.

In a further aspect of the technology, a method of securing a treatmentdevice at a location proximate a native valve of a heart of a patient.The method can include passing a first arm of the treatment devicearound a free edge of the first leaflet into a first subannular spacebehind the first leaflet; passing a second arm of the treatment devicearound a free edge of the second leaflet into a second subannular spacebehind the second leaflet; and engaging a surface of the annulus behindthe leaflets with the first and second arms to inhibit movement of thetreatment device in an upstream direction relative to the native valve.

In another aspect, an apparatus to treat a valve of a patient includesan expandable support comprising an outer surface, the expandablesupport configured for placement between the leaflets and comprising anupstream portion and a downstream portion; and a plurality of armscoupled to the expandable support, the plurality of arms comprising afirst plurality of arms and a second plurality of arms, the firstplurality of arms arranged on a first portion of the support to receivea first leaflet, the second plurality of arms arranged on a secondportion of the support to receive a second leaflet.

In a further embodiment, an apparatus for repair or replacement of aheart valve having an annulus, leaflets coupled to the annulus, andchordae tendineae coupled to the leaflets, comprises a support portionpositionable between the leaflets and having an interior to which avalve may be coupled; an anchoring portion coupled to the supportportion, the anchoring portion having a turning region configured toextend around a downstream edge of at least one leaflet, an extensionregion configured to extend from the downstream edge between the chordaetendineae to the annulus, and an engagement region configured to engagethe annulus so as to inhibit movement of the apparatus in an upstreamdirection.

In still another aspect, the present technology provides an apparatusfor repair or replacement of a heart valve having an annulus, leafletscoupled to the annulus, and chordae tendineae coupled to the leaflets,the apparatus comprising a cylindrical support configured for placementbetween the leaflets, the support having upstream and downstream endsand an interior in which a valve may be coupled; a first group of armscoupled to the support along a posterior side thereof; and a secondgroup of arms coupled to the support along an anterior side thereofopposite the posterior side; wherein each arm is configured to extendaround a downstream edge of a leaflet, between the chordae tendineae andinto engagement with the annulus so as to inhibit movement of thesupport in an upstream direction.

In another embodiment, an apparatus for repair or replacement of a heartvalve having an annulus can include a cylindrical support configured forplacement between the leaflets, the support having upstream anddownstream ends and an interior in which a valve may be coupled; and aplurality of arms coupled to the cylindrical support and extending in anupstream direction with distal tips configured to engage annulus tissueof the heart valve; wherein a first plurality of the arms have acharacteristic different than at least a second plurality of the arms,the characteristic being selected from size, shape, stiffness, angle,spacing from the support, or the number of arms within a given area ofthe support.

In another aspect of the present technology, an apparatus for repair orreplacement of a heart valve having an annulus is provided. Theapparatus can comprise a cylindrical support having upstream anddownstream ends, an interior in which a valve may be coupled, and aperimeter; and a plurality of arms coupled to the cylindrical supportand extending in an upstream direction with distal tips configured toatraumatically engage annulus tissue of the heart valve; wherein thearms are unevenly distributed about the perimeter such that at least afirst adjacent pair of arms is spaced closer together than at least asecond adjacent pair of arms.

In a further embodiment, an apparatus for repair or replacement of aheart valve having an annulus can include a cylindrical support havingupstream and downstream ends, an interior in which a valve may becoupled, and a central longitudinal axis; and a plurality of armscoupled to the cylindrical support and extending in an upstreamdirection with distal tips configured to engage annulus tissue of theheart valve; wherein at least one of the arms extends outwardly agreater distance from the longitudinal axis than at least a second ofthe arms.

In still another aspect, the present technology provides an apparatusfor repair or replacement of a heart valve having an annulus whichcomprises a cylindrical support having upstream and downstream ends andan interior in which a valve may be coupled; and at least one armcoupled to the cylindrical support and extending in an upstreamdirection with a distal tip configured to engage the annulus of theheart valve behind a leaflet thereof, the at least one arm having acolumn strength selected to maintain the position of the supportrelative to the heart valve under a force of at least about 0.5 lbfexerted against the support in the upstream direction.

In a further aspect of the present technology, an apparatus forreplacement of a heart valve comprises a cylindrical support having aninterior through which blood may flow; a valve coupled within theinterior of the support and configured to block blood flow through thesupport in an upstream direction and allow blood flow through thesupport in a downstream direction; and a plurality of arms coupled tothe support and extending in the upstream direction along an exteriorwall of the support; wherein the apparatus is movable into a pluralityof configurations comprising a first configuration in which the supportis radially contracted and each arm is in an inward position against oradjacent to the exterior wall of the support; a second configuration inwhich the support is radially contracted and each arm is in an outwardposition separated from the exterior wall by a distance sufficient toreceive a leaflet of the heart valve therebetween; and a thirdconfiguration in which the support is radially expanded and each arm ispositioned closer to the exterior wall of the support that in the secondconfiguration.

Additional aspect of the present technology are described furtherherein. It is contemplated that the embodiments as described herein maybe combined in many ways, and any one or more of the elements recited inthe claims can be combined together in accordance with embodiments ofthe present technology and teachings as described herein.

Embodiments of the present technology as described herein can becombined in many ways to treat one or more of many valves of the bodyincluding valves of the heart such as the mitral valve. The embodimentsof the present technology can be therapeutically combined with manyknown surgeries and procedures, for example, such embodiments can becombined with known methods of accessing the valves of the heart such asthe mitral valve with antegrade or retrograde approaches, andcombinations thereof.

Cardiac Physiology

FIGS. 1 and 1A shows a heart H. The heart comprises a right atrium RAand a right ventricle RV that receive blood from the body and pump theblood from the body to the lungs. The left atrium receives oxygenatedblood from the lungs via the pulmonary veins PV and pumps thisoxygenated blood through the mitral MV into the left ventricle LV. Theleft ventricle LV pumps the blood through the aortic valve AV into theaorta from which it flows throughout the body.

The left ventricle LV of a normal heart H in systole is illustrated inFIG. 1A. In systole, the left ventricle LV contracts and blood flowsoutwardly through the aortic valve AV in the direction of the arrows.Back flow of blood or “regurgitation” through the mitral valve MV isprevented since the mitral valve is configured as a “check valve” whichprevents back flow when pressure in the left ventricle is higher thanthat in the left atrium LA. The mitral valve MV comprises a pair ofleaflets having free edges FE which meet evenly, or “coapt” to close, asillustrated in FIG. 1A. The opposite ends of the leaflets LF areattached to the surrounding heart structure via an annular region oftissue referred to as the annulus AN. The free edges FE of the leafletsLF are secured to the lower portions of the left ventricle LV throughchordae tendineae CT (referred to hereinafter “chordae”) which include aplurality of branching tendons secured over the lower surfaces of eachof the valve leaflets LF. The chordae CT in turn, are attached to thepapillary muscles PM, which extend upwardly from the lower wall of theleft ventricle and interventricular septum IVS.

Referring now to FIGS. 1B to 1D, a number of structural defects in theheart can cause mitral valve regurgitation. Ruptured chordae RCT, asshown in FIG. 1B, can cause a valve leaflet LF2 to prolapse sinceinadequate tension is transmitted to the leaflet via the chordae. Whilethe other leaflet LF 1 maintains a normal profile, the two valveleaflets do not properly meet and leakage from the left ventricle LVinto the left atrium LA will occur, as shown by the arrow.

Regurgitation also occurs in the patients suffering from cardiomyopathywhere the heart is dilated and the increased size prevents the valveleaflets LF from meeting properly, as shown in FIG. 1C. The enlargementof the heart causes the mitral annulus to become enlarged, making itimpossible for the free edges FE to meet during systole. The free edgesof the anterior and posterior leaflets normally meet along a line ofcoaptation C as shown in FIG. 1C1, but a significant gap G can be leftin patients suffering from cardiomyopathy, as shown in FIG. 1C2.

FIGS. 1C1, 1C2, and 1E further illustrate the shape and relative sizesof the leaflets L of the mitral valve. It may be seen that the overallvalve has a generally kidney-like shape, with a long axis MVA1 and ashort axis MVA2. In healthy humans, the long axis MVA1 is typicallywithin a range from about 33.3 mm to about 42.5 mm in length (37.9+/−4.6mm), and the short axis MVA2 is within a range from about 26.9 to about38.1 mm in length (32.5+/−5.6 mm). However, with patients havingdecreased cardiac function these values can be larger, for example MVA1can be within a range from about 45 mm to 55 mm and MVA2 can be within arange from about 35 mm to about 40 mm. The line of coaptation C iscurved or C-shaped, thereby defining a relatively large anterior leafletAL and substantially smaller posterior leaflet PL (FIG. 1C1). Bothleaflets appear generally crescent-shaped from the superior or atrialside, with the anterior leaflet AL being substantially wider in themiddle of the valve than the posterior leaflet. At the opposing ends ofthe line of coaptation C the leaflets join together at corners calledthe anterolateral commissure AC and posteromedial commissure PC,respectively.

Mitral valve regurgitation can also occur in patients who have sufferedischemic heart disease where the functioning of the papillary muscles PMis impaired, as illustrated in FIG. 1D. As the left ventricle LVcontracts during systole, the papillary muscles PM do not contractsufficiently to effect proper closure. One or both of the leaflets LF1and LF2 then prolapse, as illustrated. Leakage again occurs from theleft ventricle LV to the left atrium LA, as shown by the arrow.

FIG. 1E shows the shape and dimensions of the annulus of the mitralvalve. The annulus is an annular area around the circumference of thevalve comprised of fibrous tissue which is thicker and tougher than thatof the leaflets LF and distinct from the muscular tissue of theventricular and atrial walls. The annulus may comprise a saddle-likeshape with a first peak portion PP1 and a second peak portion PP2located along an interpeak axis IPD, and a first valley portion VP1 anda second valley portion VP2 located along an intervalley axis IVD. Thefirst and second peak portions PP1 and PP2 are higher in elevationrelative to a plane containing the nadirs of the two valley portionsVP1, VP2, typically being around 8-19 mm higher in humans, thus giventhe valve an overall saddle-like shape. The distance between the firstand second peak portions PP1, PP2, referred to as interpeak span IPD, issubstantially shorter than the intervalley span IVD, the distancebetween first and second valley portions VP1, VP2.

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the patient may vary among patients, and although somepatients may comprise differing physiology, the teachings as describedherein can be adapted for use by many patients having variousconditions, dimensions and shapes of the mitral valve. For example, workin relation to the present disclosure suggests that some patients mayhave a long dimension across the annulus and a short dimension acrossthe annulus without well defined peak and valley portions, and themethods and apparatus as described herein can be configured accordingly.

Access to the Mitral Valve

Access to the mitral valve or other atrioventricular valve can beaccomplished through the patient's vasculature in a percutaneous manner.By percutaneous it is meant that a location of the vasculature remotefrom the heart is accessed through the skin, typically using a surgicalcut down procedure or a minimally invasive procedure, such as usingneedle access through, for example, the Seldinger technique. The abilityto percutaneously access the remove vasculature is well-known anddescribed in the patent and medical literature. Depending in the pointof vascular access, the approach to the mitral valve may be antegradeand may rely on entry into the left atrium by crossing the interatrialseptum. Alternatively, approach to the mitral valve can be retrogradewhere the left ventricle is entered through the aortic valve. Oncepercutaneous access is achieved, the interventional tools and supportingcatheter (s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners, as describedherein.

Using a trans-septal approach, access is obtained via the inferior venacava IVC or superior vena cava SVC, through the right atrium RA, acrossthe interatrial septum IAS and into the left atrium LA above the mitralvalve MV.

As shown in FIG. 1F, a catheter 10 having a needle 12 may be advancedfrom the inferior vena cava IVC into the right atrium RA. Once thecatheter 10 reaches the anterior side of the interatrial septum IAS, theneedle 12 may be advanced so that it penetrates through the septum, forexample at the fossa ovalis FO or the foramen ovale into the left atriumLA. At this point, a guidewire may be exchanged for the needle 12 andthe catheter 10 withdrawn.

As shown in FIG. 1G, access through the interatrial septum IAS mayusually be maintained by the placement of a guide catheter 14, typicallyover a guidewire 16 which has been placed as described above. The guidecatheter 14 affords subsequent access to permit introduction of theapparatus to replace the mitral valve, as described in more detailherein below.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, the use of theantegrade approach will usually allow for more precise and effectivecentering and stabilization of the guide catheter and/or prostheticvalve apparatus. Precise positioning facilitates accuracy in theplacement of the prosthetic valve apparatus. The antegrade approach mayalso reduce the risk of damaging the subvalvular apparatus duringcatheter and interventional tool introduction and manipulation.Additionally, the antegrade approach may decrease risks associated withcrossing the aortic valve as in retrograde approaches. This can beparticularly relevant to patients with prosthetic aortic valves, whichcannot be crossed at all or without substantial risk of damage.

An exemplary retrograde approach to the mitral valve is illustrated inFIGS. 1H-1I. The mitral valve MV may be accessed by an approach from theaortic arch AA, across the aortic valve AV, and into the left ventriclebelow the mitral valve MV. The aortic arch AA may be accessed through aconventional femoral artery access route, as well as through more directapproaches via the brachial artery, axially artery, or a radial orcarotid artery. Such access may be achieved with the use of a guidewire16. Once in place, a guide catheter 14 may be traced over the guidewire16. The guide catheter 14 affords subsequent access to permit placementof the prosthetic valve apparatus, as described in more detail below.

In some instances, a retrograde arterial approach to the mitral valvecan be preferred due to its advantages. Use of the retrograde approachcan eliminate the need for a trans-septal puncture. The retrogradeapproach is also more commonly used by cardiologists and thus has theadvantage of familiarity.

An additional approach to the mitral valve is via trans-apical puncture,as shown in FIG. 1J. In this approach, access to the heart is gained viathoracic incision, which can be a conventional open thoracotomy orsternotomy, or a smaller intercostal or sub-xyphoid incision orpuncture. An access cannula is then placed through a puncture, sealed bya purse-string suture, in the wall of the left ventricle near the apexof the heart. The catheters and prosthetic devices disclosed herein maythen be introduced into the left ventricle through this access cannula.

The trans-apical approach has the advantage of providing a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, it can be performed bysurgeons who may not have the necessary training in interventionalcardiology to perform the catheterizations of other percutaneousapproaches.

The prosthetic treatment apparatus may be specifically designed for theapproach or interchangeable among approaches. A person of ordinary skillin the art can identify an appropriate approach for an individualpatient and design the treatment apparatus for the identified approachin accordance with embodiments described herein.

Orientation and steering of the prosthetic valve apparatus can becombined with many known catheters, tools and devices. Such orientationmay be accomplished by gross steering of the device to the desiredlocation and then refined steering of the device components to achieve adesired result.

Gross steering may be accomplished by a number of methods. A steerableguidewire may be used to introduce a guide catheter and the prosthetictreatment apparatus into the proper position. The guide catheter may beintroduced, for example, using a surgical cut down or Seldinger accessto the femoral artery in the patient's groin. After placing a guidewire,the guide catheter may be introduced over the guidewire to the desiredposition. Alternatively, a shorter and differently shaped guide cathetercould be introduced through the other routes described above.

A guide catheter may be pre-shaped to provide a desired orientationrelative to the mitral valve. For access via the trans-septal approach,the guide catheter may have a curved, angled or other suitable shape atits tip to orient the distal end toward the mitral valve from thelocation of the septal puncture through which the guide catheterextends. For the retrograde approach, as shown in FIGS. 1H and 1I, guidecatheter 14 may have a pre-shaped J-tip which is configured so that itturns toward the mitral valve MV after it is placed over the aortic archAA and through the aortic valve AV. As shown in FIG. 1H, the guidecatheter 14 may be configured to extend down into the left ventricle LVand to evert so that the orientation of an interventional tool orcatheter is more closely aligned with the axis of the mitral valve MV.In either case, a pre-shaped guide catheter may be configured to bestraightened for endovascular delivery by means of a stylet or stiffguidewire which is passed through a lumen of the guide catheter. Theguide catheter might also have pull-wires or other means to adjust itsshape for more fine steering adjustment.

Treatment of Cardiac Valves

Embodiments of the present technology as described herein can be used totreat one or more of the valves of the heart as described herein, andcan be used for treatment of the mitral valve, or in other embodiments,the aortic valve.

FIGS. 2A1 and 2A2 show side and top views of a prosthetic treatmentapparatus 100 comprising a valve 150 mounted to a support 110 disposedin a delivery configuration 111, and a plurality of arms 120 in anoutward configuration 123 to reach behind leaflets of the mitral valveinto the subannular space on the ventricular side of the native annulus.The support 110 is generally cylindrical, being formed around alongitudinal axis 110A. The support 110 comprises an expandable skeleton140 from which the plurality of arms 120 extend. The support 110 mayfurther comprise a covering (not shown) disposed around the exteriorand/or interior walls of the skeleton 140 to block blood flow throughthe walls of skeleton 140 and/or to promote in-growth of tissue. Thearms 120 may also be covered by a coating or covering (not shown) topromote in-growth. The arms 120 can be configured to engage the nativeannulus such that the valve 150 is supported by the annulus when valve150 is closed during systole. The plurality of arms 120 can have acolumn strength to support the valve 150 and maintain its generalposition relative to the native heart tissue by engaging the annulus asdescribed herein.

The support 110 comprises an upstream portion 112 and a downstreamportion 114 and an outer surface 110S. As used herein, “upstream” shallmean the direction from which blood normally flows through the heart orvalve in question, while “downstream” shall mean the direction towardwhich blood normally flows. In the case of the mitral valve, “upstream”means the direction toward or closer to the left atrium or superioraspect of the heart, while “downstream” means the opposite direction,toward or closer to the left ventricle or inferior aspect of the heart.For the aortic calve, “upstream” means the direction toward the leftventricle or inferior end of the heart, while “downstream” means thedirection toward or closer to the aorta or aortic arch. In oneembodiment, the support 110 comprises a first side 110S1 and a secondside 110S2. A first plurality of arms 120A comprising a first tipportions 122A can be mounted to the support 110 on the first side 110S1and a second plurality of arms 120B comprising second tip portions 122Bcan be mounted to the support 110S on the second side 110S2. A firstmidline 110M divides the support roughly in half between the first side110S1 and the second side 110S2, intersecting axis 110A. A secondmidline 110M2 extends transverse to the first midline 110M, intersectingthe midline 110M at the center of the support 110 (FIG. 2A2).

The skeleton 140 may be comprised of a plurality of thin interconnectingmembers referred to herein as struts 142 or posts 144, arranged in avariety of geometrical patterns. Alternatively, the skeleton 140 maycomprise a mesh or woven construction. In one embodiment, the skeleton140 can include a plurality of struts 142 and a plurality of posts 144.The plurality of posts 144 can extend along an axial direction generallyparallel to the longitudinal axis 110A and the struts 142 can extendcircumferentially around the longitudinal axis 110A. The struts 142 canform a series of rings around the longitudinal axis 110A, wherein eachring can have a circumferentially expandable geometry. In the exampleshown, struts 142 are formed in sinusoidal configuration. Zig-Zags,closed cells, open cells, or other expandable configurations are alsopossible. The plurality of struts 142 can attach to the plurality ofposts 144 so as to define a plurality of nodes 110N. The plurality ofstruts 142 and the plurality of posts 144 may comprise a deformablematerial or a resilient or shape memory material as described herein. Insome embodiments, the plurality of arms 120 may be attached to orotherwise formed integrally with the downstream ends 114 a of the posts144 or to locations along the struts 142, or a combination thereof. Inother embodiments, the arms 120 can extend from or be coupled toanywhere on the skeleton 140, for example, to an outer surface of a post144 or strut 142 along the longitudinal axis 110A of the skeleton 140.

The plurality of arms 120 are configured to reach behind the leaflets ofthe valve and to engage the native annulus. Each of the plurality ofarms 120 can comprise a tip portion 122 (e.g., a distal tip) to contactthe annulus and a base portion 124 to couple the arm 120 to the support110. Contact with the annulus may occur, for example, in the annulargroove defined by the intersection of the superior portion of theventricular wall and the root portion the ventricular surface of themitral leaflets. In one embodiment, the arms 120, when engaging theannulus, are oriented so as to be generally orthogonal to, or at anoblique angle between about 45 and 135 degrees relative to, thesubannular surface, such that the loading exerted upon the arms 120 isprimarily a compressive, axial load. The tip portion 122 mayalternatively be positioned more downstream, that is, anywhere along theventricular surface of the mitral leaflets or along the ventricularwall. Likewise, the tip portions 122 may not be in substantial contactwith any heart structure if, for example, engagement of the plurality ofthe arms 120 with the chordae tendineae leave the plurality of arms 120positioned such that the tip portions 122 extend into free space.

Each of the plurality of arms 120 are separated from the support 110with a gap distance 130 sized to receive the leaflet between each arm120 and the outer surface 110S of support 110. An elbow portion 126extends in a downstream direction from the base portion 124 and thenmakes a turn of about 120-180 degrees in the upstream direction. Each ofthe plurality of arms 120 may comprise an extension portion 127extending between the curved elbow portion 126 and the tip portion 122.The elbow portion 126 may comprise a U-shaped curve 126U that extends tothe extension portion 127. In some embodiments, the elbow portion 126can have an arcuate shape, however, in other embodiments, the elbowportion can include a more triangular shape or a square shape thatpermits redirection of the arm 120 from a downstream trajectory to anupstream trajectory. Each of the plurality of arms 120 can extend adistance 139 below the downstream end 114 a of the downstream portion114 of the support 110. The curved elbow portion 126 can extend aroundan axis 126A located below the downstream end of the support 110. Eachof the plurality of arms 110 extends upstream a distance 138 from thedownstream end of curved elbow portion 126 to the tip portion 122 sothat the tip 122 can engage the native valve annulus while the curvedelbow portion 126 can accommodate the downstream edge of the nativeleaflet. Optionally, the arms 120 may be configured such that the nativeleaflet is compressed, folded or bunched up toward the annulus when thetip portion 122 is in engagement with the annulus.

The tip portion 122 of each of the plurality of arms 120 can be shapedto inhibit penetration of or injury to the annulus. The tip portion 122may comprise a pressure reducing tip portion 122PR shaped so that thesurface area of the tip portion 122 of the arm 120 contacting theannulus is greater than a cross sectional area of the arm 120 away fromthe tip portion 122.

The tip portions can be oriented so as to have a low profile when thesupport 110 is disposed in a delivery configuration 111 (FIG. 2A2) andhave an engagement profile when the support 110 is in an expandedconfiguration 113 (FIG. 2A3). Tip portions 122A can be curved or bentaround an axis generally parallel to longitudinal axis 110A so that thetips point toward the second midline 110M2 (FIG. 2A2).

Referring to FIGS. 2A2, 2A3 and 2A4 together, the valve 150 can beconfigured in many ways and may comprise one or more of a temporaryvalve, a replaceable valve, a removable valve or a permanent valve. Thevalve 150 comprises a plurality of leaflets 152. In one embodiment,valve 150 has a tri-leaflet configuration, although various alternativevalve configurations may be used, such as a bi-leaflet configuration.The valve 150 is adapted to allow blood flow in the downstream directionand to block blood flow in the upstream direction.

FIG. 2A3 shows the apparatus of FIGS. 2A1 and 2A2 with the support 110in an expanded configuration 113 and the valve open 150. Additionally,FIGS. 2A3-2A4 illustrated an alternative configuration for tip portions122A, wherein tip portions 122A are bent or curved around an axistransverse to the longitudinal axis 110A so that the tips 122 pointgenerally toward the center of support 110 or toward midline 110M.

FIG. 2A4 shows the apparatus of FIGS. 2A1 and 2A2 with the support 110comprising the expanded configuration 113 and the valve 150 closed.

FIG. 2A5 shows the geometry and dimensions of an individual arm 120. Thearm 120 comprises the elbow portion 126 that can extend the distance 139below the downstream end of support 110 (not shown in FIG. 2A5). Thedistance 139 can be within a range from about 0 to about 15 mm, forexample about 4 m. The arm 120 can extend from the lower end of theelbow portion 126 to the tip 122 a distance 137. The distance 137 can befrom about 10 mm to about 35 mm, for example about 20 mm. The extensionportion 127 can extend at an extension angle 135 relative to thelongitudinal axis 110A of the support 110. The extension angle 135 canbe within a range from about 10 degrees to about 50 degrees, for exampleabout 25 degrees. The extension angle 135 can determine a gap distance130 between the tip portion 122 and the outside surface 110S of thesupport 110.

FIG. 2A6 shows an apparatus 100 implanted at a native valve location inthe heart. The arms 120 of the apparatus 100 extend around a leaflet LFbetween chordae CT of a mitral valve. In some embodiments, the arms 120on one side of the apparatus 100 can be configured to extend through agap in the chordae CT near the center of the native leaflet LF. The arms120 can be sized to extend to the annulus and engage the annulus withthe tip portions 122. The arms 120 are splayed circumferentially so thattip portions 122 are spaced apart along the native annulus so as todistribute the load across a wider area of the native subannularsurface.

The tip portions 122 may have a variety of configurations adapted todistribute force and minimize tissue injury or penetration of theannulus. FIG. 2A7A shows an arm 120 having a pair of curved tips 122SKon the tip portion 122. The pair of curved tips 122SK of tip portion 122may comprise curved tips which are sufficiently flexible to be deflectedin the downstream direction when engaged by the annulus. The curved tips122SK may have sufficient resiliency to be biased in an upstreamdirection toward the annulus so as to maintain contact with the annulus.In this way, the varying elevation of the annulus can be accommodated bythe arms 120 so that each of the arms 120 can engage the annulus andbear some of the load exerted on the support 110. Alternatively, the tipportion 122 may comprise round balls as shown in FIG. 2A7B, flatteneddisk-like structures as shown in FIG. 2A7C, rings as shown in FIG. 2A7D,or other structures. Moreover, in some embodiments, the tip portions 122are configured to interact cooperatively with the support 110 to enhanceengagement with the native valve leaflets. In one configuration, the tipportions 122 point inwardly toward the longitudinal axis 110A and extendover the upstream end of the support 110 such that the native leafletsare sandwiched or compressed between the arms 120 and the support 110and are folded around the upstream end 112 a of the upstream portion 112of support 110 as shown in FIG. 2A7E.

FIG. 2A8 shows a top view of an apparatus 100 wherein the maximumdimension 122MD across each pressure reducing tip portion 122PR isoriented so as to extend generally parallel to the outer surface 110S ofthe support 110. When the support 110 is in the delivery configuration111 and the plurality of arms 120 are in the inward configuration 121,the tip portions 122 can nest and conform to the outer surface 110S todecrease the cross-sectional size of the apparatus 100. In someembodiments, adjacent pressure reducing tip portions 122PR can betouching or pressed together on the outer surface 110S of the support110, or in other embodiments, the pressure reducing tip portions 122PRcan be spaced apart along the outer surface 110S by a space 122PRA suchthat each arm 120 can have a low profile against the support 110 whilein the inward configuration 121.

In another embodiment, FIGS. 2A9-2A10 show splay angles of the pluralityof arms 120. The support 110 is shown in the delivery configuration 111and the plurality of arms 120 are shown in the outward configuration123. Each arm 120 extends from the elbow portion 126 toward the tipportion 122 at unique and variable splay angles off a midline (e.g., thesecond midline 110M2) such that the plurality of arms 120 are splayedaway from each other. In the example shown in FIGS. 2A9 and 2A10, thearms 120 (e.g., arm 120 z) closes to the second midline 110M2 can have afirst splay angle 126SA1 and the arms 120 (e.g., arm 120 x) farther fromthe midline 110M2 can have a second splay angle 126SA2 larger than thefirst splay angle 126SA1. In this example, the tip portions 122 can bespaced apart with respect to each other tip portion 122 and can span awider distance while contacting the native annulus. In this embodiment,it can be possible to more widely distribute a load on the subannularsurface (e.g., pressure or force exerted on the apparatus 100 againstthe subannular surface of the native annulus at the points of contactwith the tip portion 122) when the second/downstream heart chambercontracts. In another configuration, the splay angles 126SA1, 126SA2 areselected such that the individual tip portions 122 of each of thegroupings (e.g., rows 128A and 128B shown in FIG. 2A10) of arms 120 oneach side of support 110 are clustered together near the midline 110M2.The splay angles may also be selected such that the curved elbow portion126 forms a helical curve. Alternatively, or in combination, the elbowportion 126 can be twisted such that the extension portion 127 extendsto the tip 122 at the selected splay angle. One of ordinary skill willunderstand that each arm 120 can project from the support 110 at aunique and variable splay angle, with respect to other splay angles ofadditional arms 120 on the support 110, for accommodating a variety ofnative structures having differing shapes, sizes and load-bearingpotential.

FIGS. 2A10 and 2A11 show top and side views of angles of the pluralityof arms 120 relative to the longitudinal axis 110A and configured fortreatment of a bi-leaflet or bicuspid valve such as the mitral valve.The support 110 is shown in the delivery configuration 111 and theplurality of arms 120 in the outward configuration 123. The arms 120 arearranged such that tip portions 122 form a first row 128A on the firstside 110S1 of the first midline 110M and a second row 128B on the secondside 110S2 of the first midline 110M. In one embodiment, the other twosides of support 110, offset roughly 90 degrees from sides 110S1 and110S2, may have no arms or a much smaller number or lower density ofarms than on sides 110S1 and 110S2. In some embodiments, thecircumferential distance between an outside arm 120 x in row 128A and anoutside arm 120 y in row 128B can be substantially larger than the spacebetween adjacent arms (e.g., arm 120 x and arm 120 z) in the same row(row 128A or 128B).

First and second rows 128A, 128B or arms 120 may each form a generallystraight line, or in other arrangements, may form a peaked or arrow-likeshape. In additional arrangements, the arms 120 can be arranged in acurvilinear fashion with a curvature generally matching that of thenatural curvature of the native annulus. In some embodiments of devicessuitable for treating the mitral valve, which can have a large oval orkidney-like shaped annulus, tip portions 122 in the expandedconfiguration can be arranged to mimic or match the oval or kidney-likeshape of the native annulus and can have a radius of curvaturesubstantially larger than the radius of curvature of support 110. Forexample, support 110 may have a radius of curvature of about 10-20 mmwhen expanded, while tip portions 122 may be arranged in a curve havinga radius of about 15-30 mm. The first side 110S1 and the second side110S2 are each divided by the second midline 110M2. To extend the radiusof curvature of the tip portions 122 of the collective plurality of arms120, the arms can have varying splay angles (e.g., splay angles 126SA1and 125SA2) as discussed above, and the arms 120 can be extended fromthe longitudinal axis 110A at variable extension angles 135 (shownindividually as 135 a and 135 b in FIG. 2A11). The extension portion 127of each arm 120 can extend at an extension angle 135 relative to thelongitudinal axis 110A and/or the outside surface 110S of the support110. In one embodiment, and as shown in FIG. 2A11, the arms furthestfrom the second midline 110M2 can extend at an extension angle 135 brelative to the longitudinal axis 110A and the arms closest to thesecond midline 110M2 can extend at an extension angle 135 a relative tothe longitudinal axis 110A, wherein the extension angle 135 b is greaterthan extension angle 135 a. Referring to FIG. 2A11, the extensionportion 127 of the am 120 z closest to midline 110M2 extends with afirst extension angle 135 a relative to longitudinal axis 110A andextension portion 127 of the arm 120 x located farther from midline110M2 than arm 120 z, extends with a second extension angle 135 b,wherein the second extension angle 135 b is greater than the firstextension angle 135 a such that the plurality of tips 122 of first side110S1 are linearly aligned to form a generally straight first row 128Aand/or have a radius of curvature greater than a radius of curvature ofthe support 110. For a tri-leaflet or tricuspid valve, arms 120 may bearranged in three groups or rows offset by about 120 degrees from eachother circumferentially around the support 110, rather than two groupsor rows on opposing sides of the support 110. In other embodiments, thesupport 110 can accommodate more than three groupings or rows of arms120.

FIG. 2B-1 shows a schematic cross-sectional front elevation view of theheart with a prosthetic treatment apparatus 100 (such as the apparatus100 of FIG. 2A1) coupled within a lumen 101 near the distal end of adelivery catheter 200 for treatment of the mitral valve MV (chordaetendineae are not shown for clarity). The delivery catheter 200 ininserted through a guide 202 which has been delivered from the rightatrium through a trans-septal puncture into the left atrium LA. In someembodiments, a distal portion 270 of the guide 202 is shape-set into acurve such that a distal end 272 of the guide 202 points toward thenative mitral valve MV of the heart H.

FIG. 2B-2 shows the distal portion 270 of the delivery catheter 200 ofFIG. 2B-1, wherein the prosthetic treatment apparatus 100 is coveredwith a sheath 20 of the delivery catheter 200. The apparatus 100 caninclude an expandable support 110 and a plurality of arms 120.Constrained within a lumen 22 of the sheath 20, the expandable support110 is disposed in a radially-contracted delivery configuration 111 andthe plurality of arms 120 are arranged in an inward configuration 121for percutaneous delivery to the mitral valve MV. The sheath 20 of thedelivery catheter 200 can be located over the arms 120 when the support110 is in the delivery configuration 111 and the plurality of arms 120are in the inward configuration 121. The apparatus 100 may include anexpandable member, e.g. balloon, 190 to expand the support 110, or thesupport 110 can be a self-expanding support, or combinations thereof. Avalve 150 can be mounted within the interior of the expandable support110, or the valve 150 can be coupled to the support after implantationwhen the support 110 is in the expandable configuration 113, orcombinations thereof as described herein.

FIG. 2C is an isometric side view of the prosthetic heart valve device(e.g., apparatus 100) of FIG. 2B-2 having the catheter sheath retractedfrom the plurality of arms 120 and showing the plurality of arms 120extending outward from the support 110 for positioning at the nativevalve structure and configured in accordance with an embodiment of thepresent technology. Referring to FIGS. 2A1, 2B-C and 2C together, theexpandable support 110 comprises an upstream portion 112 comprising anupstream end 112 a of the support 110 and a downstream portion 114comprising a downstream end 114 a of the support 110. The support 110includes an outer surface 110S, which can be covered with a fabric, orother flexible and biocompatible material such as Dacron™, to integratewith tissue and minimize pervalvular leaks. The support 110 can becylindrical in shape, with a circular, oval, elliptical, kidney-shapedor other suitable cross-section, and defines an axis 110A extending fromthe upstream portion 112 to the downstream portion 114. The support 110may comprise a skeleton 140 comprised of a plurality of interconnectedstruts 142 which are deformable or which resiliently change orientationwhen unconstrained. The skeleton 140 may comprise a plurality of posts144 extending between the plurality of struts 142 to provide columnstrength to the support 110. The plurality of posts 144 and struts 142have sufficient strength to transfer a force or load applied to theapparatus 100 to the plurality of arms 120. The skeleton 140 can beformed of, for example, one or more of a malleable, balloon-deformablematerial such as stainless steel or a cobalt chromium alloy such as L605or MP35N. Alternatively or in combination, the expandable support caninclude one or more of a resilient material, shape memory material, orsuperelastic material such as Nitinol, for example. The support 110 mayalternatively by composed entirely or partially of a biocompatiblepolymer, ceramic, textile, or other suitable material.

The arms 120 may include J-hooks, fingers, columns, posts, wires, tubes,ribbons or similar structures having properties such as column strength,flexibility, resilience, etc., suitable for bearing a load or forceexerted on the apparatus 100. The arms 120 can have variouscross-sectional geometries, including round or polygonal, and can havedifferent geometries at different locations along their length. Forexample, the curved elbow portions 126 may be circular in cross-section,while other regions of the arms 120, such as those that engage thenative leaflets may be more flattened to have a broader area of contactwith the leaflets. Referring to FIGS. 2B-2 and 2C together, theplurality of arms 120 are coupled to the support 110 near the downstreamportion 114, although the arms 120 may alternatively be coupled to thesupport 110 at any location within the upstream and downstream portions112, 114. The arms 120 have a base 124 coupled to the support 110, a tipportion 122 configured to engage the native valve annulus (describedmore fully below), a curved elbow portion 126 coupled to the base 124,and an extension portion 127 extending between the curved elbow portion126 and tip portion 122. The arms 120 can be folded against the outersurface 110S of the support 110 in the delivery configuration 111 (shownin FIG. 2B-2). In some embodiments, the tip portions 122 extend abovethe upstream portion 112 of the support 110 in the inward configuration121, so as to decrease a cross-sectional size of the apparatus 100 whenthe support 110 is in the delivery configuration 111 and the pluralityof arms 120 are in the inward configuration 121. The tip portions 122may further be movable to an inward configuration 121 when the support110 is in the expanded configuration 113, wherein the tip portions 122contact the native valve annulus very close to the base of each nativevalve leaflet. The arms 120 may also push the native leaflets againstthe outer surface 110S of support 110 to help anchor the apparatus 100to the native tissue and to inhibit perivalvular leaks.

In other embodiments, the arms 120 are shorter in length so as to extendonly partially along the length of the support 110, with tip portions122 being aligned with a middle region (e.g., between portions 112 and114) of support 110. In the inward configuration 121, the arms 120 maybe twisted so that the tip portions 122 are aligned more tangentiallywith the outer surface 110S of the support 110 so as to lie against thesupport 110 when covered with the sheath 20 to provide a narrowcross-sectional profile.

The curved elbow portion 126 of each arm 120 may be configured toresiliently urge the arm 120 outward from the inward configuration 121(FIG. 2B-2) to the outward configuration 123 (FIG. 2C) when theplurality of arms 120 are unconstrained. Referring to FIGS. 2B-2 and 2Ctogether, the curved elbow portion 126 can extend downward (or distally)from the downstream end 114 a of the downstream portion 114 of thesupport 110 and define an arcuate or U-shaped turnaround portion 126Ufrom which the extension portion 127 extends upwardly along the outersurface 110S of the support 110. The curved elbow portion 126 may extendabout an axis of rotation 126A located below the end 114 a of thedownstream portion 114. Further, the curved elbow portions 126 mayextend radially inward toward the central longitudinal axis 110A, whichmay reduce the overall profile of the apparatus 100 during delivery(shown in FIG. 2B-2). In addition, the delivery configuration mayposition the elbow portions 126 such that they are engaged by theballoon, if present, used to expand the support 110 from the delivery111 to the expanded 113 configurations. Upon expansion, the balloon mayurge the elbow portions 126 radially outward, thereby urging tipportions 122 radially inward toward the outer surface 110S of thesupport 110. This may help to push the leaflet tissue against thesupport 110 for improved perivalvular sealing, and may further compressthe leaflet tissue between the arms 120 and the support 110, therebyenhancing the anchoring of apparatus 100.

The plurality of arms 120 can be a unitary or integral part of thesupport 110 or, in another embodiment, the arms 120 can be welded,bonded, pinned, pivotably or slidably coupled by a hinge or slidingmechanism, or otherwise affixed to the support 110. In some embodiments,the arms 120 and support 110 are laser cut from a single tube ofmaterial such as stainless steel or cobalt chromium alloy. The arms 120can then be formed into the desired unbiased configuration, optionallyusing heat to assist in forming or setting the ultimate shape.

In some arrangements, the plurality of arms have sufficient columnstrength and resistance to buckling to maintain the position of thesupport 110 relative to the native valve by engagement of the arms 120with the annulus, as described more fully below. In the same or otherarrangements, the arms 120 can have sufficient resilience to self-expandfrom the inward configuration 121 when unconstrained, and havesufficient flexibility to be deflected and repositioned whenencountering rigid tissue structures during deployment.

The loading of the plurality of arms 120 will depend on the size of thenative valve and the subject's blood pressure. As shown in Table 1below, for a valve 25 mm in diameter, the force of blood pressure duringsystole can exert a load of about 1.8-3.1 lbf (about 7.8N-13.7 N) on thesupport 110. For a valve 29 mm in diameter, the systolic load on thesupport may be about 2.4-4.2 lbf (10.6N-18.5N). This load is distributedacross the features that are in contact with the anatomy. The load maybe supported by the arms 120, and, in one embodiment, the load may bespread evenly among the arms 120, so that the load can be divided by thenumber of arms. For example, with an apparatus having 10 arms, eachindividual arm 120 may see a load of about 0.2-0.4 lbf (1.1N-1.9N). Inthese arrangements, the arms 120, when restrained by engagement with theannulus, have a column strength sufficient to withstand these forceswithout buckling. Some flexing or slight deformation may be acceptablein some embodiments, however, arms 120 generally are configured tomaintain the position of the support 110 relative to the annulus whileunder this loading. In other arrangements, the load may not be spreadevenly among the arms 120 such that the load is distributed toindividual arms in an uneven or variable manner. In these arrangements,the arms 120 can be configured to withstand higher loads, e.g. for a10-arm embodiment, each arm can be configured to withstand a load of atleast about 0.5 lbf, or in another embodiment at least about 1 lbf, andin a further embodiment at least about 2 lbf, without buckling,fracturing or otherwise failing. In embodiments with fewer arms, higherloads can be encountered by each individual arm, while devices havingmore arms may have each arm 120 receiving lower loads.

TABLE 1 Mitral Valve Load Parameters. Load on 25 Load on 29 Systolicpressure mm valve mm valve (mmHg) (N/mm{circumflex over ( )}2) (N) (lbf)(N) (lbf) 120 0.0160 7.8 1.76 10.6 2.37 210 0.0280 13.7 3.09 18.5 4.15

The values of Table 1 are based on the following model aspects andvalues. The systolic pressure acts as the pressure gradient on themitral valve even though there is some pressure in the left atrium, andthe true pressure gradient is less than the peak systolic pressure. Thesystolic pressure is shown for ranges from about 120 mmHg (normal) to210 mmHG (far above the 160 mmHg threshold for Stage 2 hypertension).The pressure gradient is applied to the valve area, so for a givenpressure, the larger the valve area, the greater the load.

The arms 120 can be sized and positioned in many ways so as to have acombination of rigidity, flexibility, and resilience that is appropriatefor deploying and anchoring a replacement heart valve. The arms 120 maycomprise sufficient rigidity to brace against the subannular rim and topush against the leaflets and/or chordae (for mitral valve replacementdevices) so as to maintain position of apparatus 100 with respect to thenative valve. For example, assuming a hypertensive systolic pressure of200 mm Hg (0.0266 N/mm2) acting as a pressure gradient on a 25 mmdiameter valve, the load on the device can be about 13.1 N (2.94 lbf).Divided evenly across 10 arms, each arm will receive a load of 0.294lbf. For a stainless steel arm, each arm have a circular cross-sectionwith a diameter of at least about 0.016 in (0.41 mm), a length of 0.787″(20 mm), and may be angled at about 15-20° away from the skeleton body.

The material and geometry selected for the arms can be used to determinethe necessary dimensions. For an arm made from 316 stainless steelhaving minimum ultimate tensile strength of about 75 ksi (per ASTMA240), a minimum arm diameter may be 0.016″, for example. Arms ofdifferent cross-sectional shapes can have a similar bending moment ofinertia, and increasing the number of arms on a prosthetic heart valvedevice can allow for a decrease in individual arm cross-sections. Insome embodiments, weaker, softer, more brittle, or more flexiblematerials may require larger cross-sectional dimensions and/or morerigid geometries.

Referring back to FIGS. 2B-1 and 2B-2, the arms 120 can fold up againstthe skeleton 140 of the support 110 to create a compact profile fortranscatheter delivery, which can be achieved with flexibility and/or asmall cross-section, for example. Various embodiments of the apparatus100 can be sized to fit in a 24 Fr lumen catheter (approximately 8 mm indiameter) for delivery. For example, the support 110 in the deliveryconfiguration 111 may have a diameter of about 6.5 mm, and the pluralityof arms 120 in the inward configuration 121 may add an additional 0.75mm, such that the total diameter of the apparatus 100 can be about 8 mmor less which can be accommodated in the 24 Fr lumen catheter.

The plurality of arms 120 may nest within recesses or holes (not shown)in the outer surface 110S of the support 110 to reduce an overallprofile or to accommodate a support 110 having a larger cross-section.

Referring to FIG. 2C, the plurality of arms 120 can be resilient todeploy away from the support 110 with a sufficient gap for receiving thenative valve leaflets between the arms 120 and the skeleton 140. Theplurality of arms 120 can be deployed away from the support 110 using avariety of mechanisms and resilient materials. In some embodiments, thearms 120 are resiliently biased toward the outward configuration 123 andmay be deployed by retracting the sheath 20 (shown in FIG. 2B-2), orextending the device 100 out of a cannula, or otherwise releasing thearms 120 from a radial constraint. The arms 120 may further beconfigured to move radially inward relative to the outer surface 110S ofsupport 110 when the support 110 is expanded to the expandedconfiguration 113. In this way, the arms 120 may engage and grip thenative leaflets as the skeleton 140 expands, sandwiching the leafletsbetween the arms 120 and the support 110 so as to a) reduce perivalvularleaks around the outside surface 110S of the support 110, and b) toenhance the anchoring of the device 100 to the native valve structure.In alternative embodiments, the arms 120 may be unbiased and instead,configured to naturally reside in an inward position (e.g.,configuration 121) close to or against the outer surface 110S of thesupport 110, or in another embodiment, in an intermediate positionbetween an outward configuration for receiving the leaflets, and aninward configuration against the support 110. Further, the radialexpansion of support 110 from the delivery configuration 111 to theexpanded configuration 113 can close the gap between the arms 120 andthe support 110, such that the arms 120, when unbiased, are disposedagainst or in close proximity to the outer surface 110S of the support110.

In various arrangements of the prosthetic heart valve device disclosedherein, the plurality of arms 120 may be sufficiently rigid so as to bepushed or pulled up along the ventricular wall; however, the arms 120can also be provided with flexibility and resilience so that the arms120 or tip portions 122 do not damage cardiac tissue or get snagged inrecesses in the wall of the downstream heart chamber. The plurality ofarms 120 may also have flexibility and resilience so as to be deflectedout of the way if engaged by obstructions such as papillary muscles andchordae as the arms are moved into position and engage a subannularsurface of the annulus. The arms 120 may also be flexible land resilientso as to absorb some of the cyclic loading experienced by an implantedapparatus 100, and to decrease irritation and puncture of anatomicalstructures following implantation.

During percutaneous delivery, the support 110 and the plurality of arms120 may be held within catheter 20 in a compressed configuration, withan overall diameter of about 5-8 mm, for example, with the support inthe delivery configuration 111 and the plurality of arms in the inwardconfiguration 121 (shown in FIGS. 2B-1 and 1B-2). In some embodiments,the arms 120 or, selectively, outmost arms 120 of each row 128 orgroupings of arms 120, can be rotated against the support 110 decreasethe overall transverse profile, for example by twisting, bending, orfolding individual arms 120 (FIG. 2A2). In other arrangements, any arm120 or selected individual arms can be rotated to decrease the overalltransverse profile.

FIG. 2C shows an isometric view of the prosthetic treatment apparatus100 wherein the support 110 is in the delivery configuration 111 (sheath20 in FIG. 2B2 pulled away) and arms 120 are extending outward from thesupport 110 in the outward configuration 123 for placement behind thenative leaflets. FIG. 2C1 shows a top (upstream) view of the apparatus100 configured as shown in FIG. 2C. When the tip portions 122 ofplurality of arms 120 are positioned distally of the native leaflets,the sheath can be withdrawn to allow the arms to move from the inwardconfiguration 121 to the outward configuration 123.

In the relaxed and unbiased outward configuration 123, the plurality ofarms 120 may extend radially outward from the support 110 at variousangles (e.g., extension angles 135 and splay angles 126SA) and in agenerally upstream direction providing a gap distance 130 between thearms 120 and the outer surface 110S of the support 110 (FIGS. 25A,2A9-2A11). In some embodiments, the arms 120 can be arranged atextension angles 135 within a range from about 5-40 degrees, or in otherembodiments from about 10-30 degrees, relative to the outer surface 110S(or axis 110A) and while in the outward configuration 123 (shown inFIGS. 2A5 and 2A11).

Referring back to FIG. 2C, each of the plurality of arms includes a baseportion 124 and each arm can extend from the base portion 124 to a tipportion 122. Each base portion 124 couples the arm 120 to the downstreamportion 114 of the support 110. The base portion 126 can be coupled tothe support 110 using a variety of techniques known in the art (e.g.,welding, pins, clips, adhesives or other mechanical techniques forattaching the base portion 126 of the arm 120 to the support 110). Inone embodiment, the base portion 124 of each arm 120 may be integrallyformed with the arm 120 and, in some arrangements to the support 110. Inanother embodiment, the base portion 124 may comprise a separatecomponent which is welded, pinned, or otherwise coupled to the arm 120and/or support 110. The base portion 124 may comprise a movable couplingor a component of a movable coupling (e.g., mechanism) such that thearms 120 or portions of the arms (e.g., base portion 124, elbow portion126 and or extension portion 127) are length and/or height adjustable.In one example, the base portion 126 may be sized to pass through a tubewelded to the downstream portion 114 so that the base portion 126 canslide through the tube to alter the height of the tip portion 122relative to support 110.

As shown in FIG. 2C, intermediate or elbow portion 126 can extend fromor otherwise be attached to the base portion 124. The elbow portion 126can be curved or arcuate in shape and may be configured to deform in amanner which repositions the arm 120 when the support 110 is expandedfrom the deliver configuration 111 to the expanded configuration 113. Inthis manner, the elbow portion 126 is configured to vary the gapdistance 130 between the outer surface 110S and the tip portions 122(refer also to FIG. 2A5). In one or more embodiments, the elbow portion126 has a cam portion 126C positioned to be engaged by a deployedballoon of the delivery catheter. The cam portion 126 can be displacedradially outward away from the longitudinal axis 110A of the support 110by the balloon such that the cam portion 126 is outside of a verticalalignment with the support 110 and so as to reposition the arm 120 tobring the tip portions 122 closer to the outer surface 110S (e.g.,decrease the gap distance 130). This radially outward displacement ofthe cam portion 126C can position the plurality of arms 120 closer tothe outer surface 110S such that the outward configuration 123 comprisesa second outward configuration 123B to compress the leaflets between thearms 120 and the outer surface 110S of the support 110, for example.

As described above, when the arms 120 are in the outward configuration123 and the support 110 is in the unexpanded delivery configuration 111,the individual arms 120 each extend away from the surface 110S of thesupport 110 by the gap distance 130. The gap distance 130 may correspondto a radial distance extending between the outer surface 110S and thetip portion 122 of each arms 120, or alternatively, may correspond toanother radial distance extending between the outer surface 110S andanother position along the extension portion 127 of the arm 120.

Referring to FIGS. 2C and 2C1 together, the plurality of arms 120 maycomprise a first plurality of arms 120A extending along a first row 128Aand a second plurality of arms 120B extending along a second row 128B.The first plurality of arms 120A can receive a first leaflet and thesecond plurality of arms 120B can receive a second leaflet.

In one embodiment, the plurality of arms 120A and 120B may be arrangedin two rows 128A and 128B, respectively, on opposing sides of thesupport 110. The gap distance 130 of each of the plurality of arms 120A,120B may vary among individual arms. For example, arms 120 closest tothe second midline 110M2 of the support can have a first gap distance130 while arms furthest from the second midline 110M2 can have a secondgap distance 130 greater than the first gap distance 130. In thisembodiment, the gap distances 130 can be arranged such that the arms 120and/or tip portions 122 can be aligned in generally straight or, inanother embodiment, curvilinear rows 128. As described herein, rows 128may comprise a generally straight line, a curved line, a zig-zag,sinusoidal shape, or other configuration. In some embodiments, the rows128 are straight or form a slight curve with a radius of curvaturesubstantially larger than that of the outer surface 110S. With a row 128is shown, the gap distance 130 of each of the tip portions 122 may bevaried in many ways to achieve a variety of different arrangements ofarms 120 or tip portions 122 so as to position the tip portions 122against the native annulus and/or to receive the leaflets of the treatedvalve (e.g., the mitral valve).

In additional arrangements, arms 120A on a first side 110S1 of support110 may be different in number, may be in a different arrangement, maybe disposed at difference angles (e.g., extension angles 135 or splayangles 126SA) in the outward configuration 123, may have different sizesor shapes, may be more or less flexible, or may have other propertiesdifferent from the arms 120B on a second side 110S2 of the support 110.This enables the arms 120 in each row 128A or 128B, or other groupingsof the arms 120, to be tailored to receive a particular leaflet of thenative valve and/or accommodate the unique physiology of particularleaflet and surround anatomy. For a particular valve, such as the mitralvalve, in which the two leaflets are very different in shape and size,and where the surrounding anatomy is very different around the anteriorleaflet than around the posterior leaflet, this variability andindependent adaptability of the arms 120A, 120B on different and/oropposing sides of the support 110 can be useful for providing unique andcustom fits of the devices/apparatus to target native valve structuresin a variety of patients and in a variety of unique disease states. Inparticular, in the case of the mitral valve, the anterior leaflet isdisposed adjacent to the left ventricular outflow tract (LVOT) forwhich, in some embodiments, obstruction should be avoided. Further, thewall of the left ventricle is farther away from the anterior leafletthan a corresponding distance to the ventricle wall near the posteriorleaflet. As such, arms 120A, for example, configured to capture andengage the anterior leaflet may not be able slide along a wall of theventricle to guide the arms to the subannular surface. Thus, in someembodiments, arms 120A on the first side 110S1 of support 110 can beconfigured, in the outward configuration 123, to extend from the support110 at a shallower angle and/or to have a shorter gap distance 130 thanthe arms 120B on the second side 110S2 of the support 110 (shown in FIG.2C1). In this way, the arms 120A on the first side 110S1 can bepositioned to capture the anterior leaflet while minimizing obstructionof the left ventricular outflow tract, and the more widely separatedarms 120B on the second side 110S2 can more easily capture the posteriorleaflet while being guided toward the annulus by engagement with theleft ventricular wall.

The first plurality of arms 120A and the second plurality of arms 120Bcan be arranged in many ways to receive the corresponding first orsecond leaflets. The first plurality of arms 120A and the secondplurality of arms 120B may comprise similar components oriented aroundthe longitudinal axis 110A so as to define one or more planes ofsymmetry. For example, the first plurality of arms 120A can extend froma first side of the support 110S1 and the second plurality of arms 120Bcan extend from a second side of the support S2, wherein a midline 110Mdivides the support 110 between side 110S1 and side 110S2. A secondmidline 110M2 perpendicular to midline 110M can further divide each ofthe first side and the second side. In some embodiments, the gapdistance 130 associated with each individual arm 120 can increaseprogressively with respect to distance from the second midline 110M2.With aortic or other tri-leaflet valve embodiments, the first pluralityof arms 120A may extend from a first portion of the support 110, thesecond plurality of arms 120B may extend from a second portion of thesupport 110, and a third plurality of arms (not shown) may extend from athird portion of the support 110, forming three rows in a generallytriangular shape such that each of the plurality of arms 120 extendingfrom the corresponding portions of the support 110 can be aligned withone of the native valve leaflets.

As described above, the plurality of arms 120 in each row 128 can besplayed away from each other arm 120. The plurality of arms 120 canextend from the base portions 124 to the tip portions 122 at differentsplay angles (e.g., 126SA1 and 126SA2 shown in FIG. 2A9) so that adistance between adjacent tip portions 122 is greater than a distancebetween adjacent base portions 124. For example, the arms 120 furtherfrom the second midline 110M2 (such as arm 120 x shown in FIG. 2A10) canhave a greater splay angle relative to the axis 110A, than those arms120 closer to the second midline (such as arm 120 z shown in FIG. 2A10).The plurality of arms 120 in each row 128 might alternatively be biasedtoward the second midline 110M2 so as to be grouped more tightlytogether. In this embodiment, the distance between adjacent tip portions122 is less than a distance between adjacent base portions 125. Thisarrangement may facilitate the placement of the group of arms 120through a gap in the chordae near the center of a native mitral valveleaflet.

The plurality of arms 120 can be configured to deflect laterally inresponse to tissue resistance. For example, each of the plurality ofarms 120 can be configured to deflect in response to contact with one ormore of the chordae tendineae, such that the arm 120 can deflect awaythe chordae tendineae to avoid entanglement and decrease distortion tothe leaflets as the arms 120 are advanced toward the annulus. Forexample, the elbow portion 126 of each arm 120 can be configured toallow deflection of the tip portion 122, while the extension portion 127can provide suitable column strength to the arm 120. Accordingly, theelbow portion 126 may comprise a flexible material having a sufficientresiliency so as to assist transition of the arm 120 between the inwardconfiguration 121 and the outward configuration 123, and so as todeflect in response to contact with the chordae or other heart tissue.In some embodiments, the arm 120 may comprise materials similar to theskeleton of the support 110, while the cross-sectional size andcurvature of the elbow portion 126 can be configured to provideresilient deflection of tip portion 122 without substantial deformationof the shape and positioning of the elbow portion 126.

In accordance with some embodiments of the present technology, the tipportion 122 of the plurality of arms 120 can be configured to avoidtrauma to and inhibit penetration of the annulus or other heart tissues.The tip portion 122 may comprise a surface or material to atraumaticallycontact and/or engage the annulus while avoiding penetration of theannulus tissue. In some embodiments, the tip portion 122 of each of theplurality of arms 120 may comprise a pressure reducing tip portion122PR. The pressure reducing tip portion 122PR may comprise any ofvarious structures configured to distribute force over a wider area ofcontact and avoid penetration of the tissue. Such structures caninclude, for example, a bumper, broadened foot, disk, curved tip, loop,tube, cap, eyelet, mitten, sleeve, sheath, ball, golf club head-shaped,teardrop shaped structure or other such structures known in the artconfigured to atraumatically apply pressure to tissue while avoidingpenetration or trauma to the tissue. In the embodiment shown in FIG. 2C,pressure reducing tips 122PR can be formed at a right angle to extensionportions 127 and generally orient inwardly toward the longitudinal axis110A. The upstream-facing surfaces of the pressure reducing tips 122PRcan be flattened and broadened to increase the area of contact with theannulus tissue. In some embodiments, the pressure reducing tips 122PRcan be configured to extend over the upstream end 112Aa of the support110 so as to minimize the cross-sectional profile of the apparatus 100while in the delivery configuration 111. Alternatively, arms 120 may beshorter in length, and the pressure reducing tips 122PR may extend intoholes or recesses in the outer surface 110S of the support 110. Invarious embodiments, the pressure reducing tip portion 122PR may beintegrally formed with the arm 120 or may be a separate component of thearm that is welded, bonded, mechanically attached or otherwise coupledthe arm 120. The pressure reducing tip 122 PR may be the same materialas the arm 120 or may be a different material, including metal, polymer,fabric, ceramic or other biocompatible material. In some embodiments,the pressure reducing tip portion 122PR can have a maximumcross-sectional area corresponding to a maximum dimension 122MD acrossthe pressure reducing tip portion 122PR (shown in FIG. 2C). Thecross-sectional area of the pressure reducing tip portion 122PR can begreater than a maximum cross-sectional area of the base portion 124, amaximum cross-sectional area of the curved elbow portion 126, or amaximum cross-sectional area of the extension portion 127, for example.Alternatively, the tip portion 122 contacting the annulus may comprise across-sectional size and maximum dimension 122MD similar to the baseportion 124, the elbow portion 126 and/or the extension portion 127. Forexample, each arm 120 may extend from the base portion 124 to the end ofthe tip portion 122 with a substantially uniform cross sectional size,and the cross-sectional size of the tip portion 122 can be sufficientlylarge so as to inhibit penetration of the annulus. The pressure reducingtip portion 122PR may also comprise a sleeve of flexible material suchas, for example, Dacron™ or PTFE placed over each tip portion 122 andadapted to not only inhibit penetration of the annulus, but, in someembodiments, to encourage or promote in-growth of tissue around the tipportion 122.

While in some embodiments, it generally can be desirable to avoid traumaand penetration of the native annulus, in some embodiments the tipportions 122 may be configured to penetrate the annulus partially orentirely in order to more securely anchor the apparatus 100 to thenative valve. In such embodiments, tip portions 122 may includesharpened distal tips to enable penetration, and/or barbs, hooks orother suitable structures to resist removal from the tissue afterpenetration. In addition, the tip portions 122 may further include adepth limiting structure such as a hilt or flange extending around thearm 120 spaced a desired distance from the tip portion 122 to limit thedepth of penetration into the annulus. In some embodiments (not shown),the sharpened distal tips may be retractable within the extensionportions 127 of the arm 120 such that the penetrating portions (notshown) can be in a retracted state while the apparatus 100 is beingpositioned with the native valve region and can be in an extended statewhen contact is made with the desired target region of the subannularsurface, for example. In this manner, the sharpened tip portion and/orpenetrating tip portions can avoid trauma, cutting, or scraping of anyother heart tissue during deployment.

In further embodiments, the extension portion 127 and/or the tip portion122 of each of the plurality of arms 120 may comprise one or more of ananchoring structure, barb, bump, ridge, scale, sintering, a roughenedsurface, polymeric or fabric coverings, or hooks on their upstreamand/or inward-facing surfaces configured to enhance friction with orcouple to the annulus, back sides of the native leaflets, chordae, heartwall, or other surrounding structures to inhibit movement of theapparatus 100 once implanted.

Referring to FIG. 2C2, each of the plurality of arms 120 can originallyinclude a length adjusting mechanism 136 to adjust a length of the armsand/or the height 138 of tip portions 122 relative to support 110 and/orelbow portion 126 in response to contact with the annulus. In someembodiments, the length adjusting mechanism can be self-adjusting, andin other embodiments, the mechanism can be manually or operativelyadjustable. In a further embodiment, the mechanism 136 may be configuredto lock each of the arms 120 into position with a desired degree ofaxial rigidity when the arm 120 engages the annulus at the desiredheight 138. In some embodiments, the height 138 of each of the tipportions 122 may correspond to a distance along the axis 100A betweenthe tip portion 122 and the base portion 124. In some embodiments, themechanism 136 may comprise one or more of a spring, a slider, a hypotube, a telescopic joint or a deflectable portion of the plurality ofarms. One of ordinary skill will recognize other mechanism 136 suitablefor self adjustment or manual adjustment of arm length.

In some arrangements, the plurality of self-adjusting arms 120 can bewell suited for use with devices used to implant at the native mitralvalve region, as the mitral valve may have a non-uniform geometry thatcan vary among patients. In one embodiment, the mechanism 136 maycomprise a telescopic configuration for adjusting and locking each arm120. In one example, the tip portions 122, which may include a bumper orenlarged surface, may be coupled to a hypodermic tube 136T which canslide up and down over an extension portion 127 of the arm 120. Aninternal compression spring 136S may bias the tube 136T in an upstreamdirection so tip portions 122 are urged toward the annulus. The springs136S may be further compressible from this position in response totissue contact. When the support 110 is moved in an upstream directionwith the plurality of arms 120 extending behind the leaflets, the arms120 which contact the lower portions of the annulus first can start tocompress, so as to allow additional arms 120 to contact the higherportions of the annulus. In exemplary embodiments, the height 138 to tipportions 122 will be self-adjusting within a range of about 1-15 mm tomaintain engagement with the higher and lower portions of the annulus.

The self-adjusting the length of the arms 120, for example due to theinternal springs 136S, can be expected to last a few hours afterimplantation. After that time, blood in the space between the hypo tube136T and the strut over which it slides may cause the mechanism 136 toseize up or otherwise prevent further movement, thereby locking themechanism 136 and providing a stable or static length of the arm 136. Inthe locked configuration, the plurality of arms 120 can support thehemodynamic load applied to the apparatus 100 with each second heartchamber contraction (e.g., heartbeat). It is also understood that themechanism 136 to adjust and lock each arm 120 can be formed inadditional ways, including, for example with telescoping tubes fittedwith friction locks, spring buttons, cam locks, ratchet system, orhydraulic pressure resistance.

When the apparatus 100 has been positioned in the left ventricle withthe arms 120 released in the outward configuration as shown in FIG. 2C,and the support 110 still in the unexpanded delivery configuration 111,the apparatus 100 can be moved up, down or sideways as appropriate so asto allow the arms 120 to slip around the lower edges of the leaflets,through the gaps between the chordae (if being placed at the mitralvalve region), and into the space “behind”, i.e. radially outside, thenative valve leaflets. In some embodiments, the arms 120 are arrangedsuch that most or all of the tip portions 122 are disposed in a middleregion of each leaflet where there are fewer chordae and a significantgap is present between the groups of chordae going to each papillarymuscle. Accordingly, the arms 120 can pass through the chordae towardthe annulus.

The plurality of arms 120 may comprise a first outward configuration123A prior to expansion of the balloon (not shown) and a second outwardconfiguration 123B after expansion of the support 110 with the balloonand as illustrated in FIGS. 2C3 and 2C4, respectively. Referring to FIG.2C3 and in the first outward configuration 123A, each of the pluralityof arms 120 are separated from the outer surface 110S of support 110 bya gap distance 130A, and each of the tip portions 122 are separated fromthe outer surface 110S by a gap distance 132A. The arcuate or elbowportion 126 extends below the downstream portion 114 of the support 110so as to engage the balloon, if present, with the cam portion 126C, asdescribed above. When the support 110 expands from the deliveryconfiguration 111 to the expanded configuration 113, the balloon canengage the cam portion 126C urging the plurality of arms to transitionfrom the first outward configuration 123A to the second outwardconfiguration 123B. The cam portion 126C can move radially outward awayfrom the longitudinal axis 110A of the support such that the cam portion126, in some embodiments, is outside of a vertical alignment with thesupport 110. As the cam portion 126 moves radially outward with pressurefrom a balloon or other expansion device, the axis 126AA (FIG. 2C3) ismoved outward to axis position 126AB (FIG. 2C4) and the extensionportion 127 and the tip portion 122 are both urged closer toward theouter surface 110S. The gap distance 130B between the arms 120 and theouter surface 110S is decreased in the second outward configuration 123Bas compared to the first outward configuration 123A, and the gapdistance 132B between the pressure reducing tip portion 122PR and theouter surface 110S is similarly decreased in the second outwardconfiguration 123B. As the arms 120 transition from the first outwardconfiguration 123A to the second outward configuration 123B, the arms120 can engage and trap the leaflet against the outer surface. In someembodiments, the plurality of arms 120 can include a shape memorymaterial which can promote similar movement between the configurations123A and 123B.

In addition to the inward movement of the arms 120 relative to the outersurface 110S, the plurality of arms 120 can have a twisting action whentransitioning from the first outward configuration 123A to the secondoutward configuration 123B, as shown schematically in FIGS. 2C5 and 2C6,respectively. In the first outward configuration 123A as seen from thedownstream direction shown in FIG. 2C5, the cam portion 126C of each ofthe plurality of arms 120 extends inclined at an angle away from theaxis 110A. When a delivery balloon expands (not shown), the cam portion126C engages the balloon and twists the arm 120 about base portion 124and moves the tip portion 122 toward the outer surface 110S withtwisting movement 123T. The twisting can splay the arms 120 when thesupport 110 expands (FIG. 2C6). The twisting of arm 120 about the baseportion 124 allows the arm 120 to be drawn toward the annulus (notshown) from a location along the leaflet having few chordae (FIG. 2C5)to a position that engages the annulus and extends along the leaflet tolocations having a higher density of chordae (FIG. 2C6). The pluralityof arms 120 can be configured to move similarly with shape memorymaterial, for example.

FIG. 2D is a schematic illustration showing a view from above aprosthetic heart valve device (such as apparatus 100) positioned withina native valve and showing the support 110 in an expanded configuration113 and the plurality of arms 120 extending outward from the support 110to reach behind native leaflets along a central portion of the leafletsbetween the chordae tendineae CT, and engage a subannular region of thenative annulus AN. For clarity, the tips 122 of the arms 120A, 120B areshown in FIG. 2D even though they are below the leaflets of the nativevalve. The rows 128A and 128B of the plurality of arms 120A, 120B andthe midline 110M can be aligned with the long dimension of the annulusAN, such that one leaflet (shown individually as LF1 and LF2) can beengaged with each row (row 128A and 128B, respectively). For the mitralvalve, the arms 120 can be configured to slip between the chordaetendineae in proximity to the edges of the leaflets LF1 and LF2, ratherthan down closer to the papillary muscles. Ultrasound, such as anechocardiogram, or fluoroscopic imaging can be used to align the firstplurality of arms 120A and the second plurality of arms 120B with thelong dimension of the mitral valve and to confirm this alignment andpositioning.

FIGS. 2E and 2F are side and top views, respectively, of a prostheticheart valve device (such as apparatus 100) showing the support 110 in anexpanded configuration 113 and in position within the native mitralvalve. The arms 120 are shown in FIG. 2F for clarity, even though theywould otherwise be obscured from view by the native leaflet. When eachof the plurality of arms 120 has been determined to be appropriatelypositioned behind the leaflets L, the apparatus 100 can be moved in theupstream direction until the tip portions 122 of the arms 120 are placedagainst the annulus A. The surgeon may feel or otherwise sense the arms120 contacting the annulus A when the support 110 is moved and guidedalong the native valve. Depending upon which native valve is beingreplaced and from which access site as described herein, the apparatus100 may be pulled or pushed so as to engage the annulus A and theleaflets L. In some embodiments, the support 110 can be expanded fromthe delivery configuration 111 to the expanded configuration 113 byballoon expansion. Alternatively, the support 110 may be configured toself-expand into the expanded configuration 113. In some embodiments,the gap distance 132 between the tip portions 122 and the support 110can decrease as the support 110 is expanded, either by deformation ofthe arms 120 to a more inward configuration, or by the radial expansionof the support 110 toward the arms 120, or a combination thereof. Inthis way, the native leaflets may be compressed or folded between thearms 120 and the outer surface 110S of the support 110 as the support110 expands from a delivery configuration 111 to an expandedconfiguration 113. The compression or folding of the arms 120 can engagethe leaflets with pressure so as to inhibit downstream movement ofapparatus 100 when blood flows in the downstream direction throughsupport 110, e.g. during diastole. In addition, the arms 120 may pressthe native leaflets against the outer surface 110S to inhibit blood flowaround the outside of support 110 during systole.

In some embodiments, the arms 120 are configured to move inwardly towardthe surface 110S as the support 110 is expanded so as to more accuratelyengage the annulus A and/or more firmly engage the leaflets L. Referringback to FIG. 2C, the arms 120 may have cam portions 126C along elbowportions 126 which can be configured to be engaged by an expandablemember (e.g. balloon) on the delivery catheter. The cam portions 126Care configured to deflect a downstream end of the arms 120 (e.g., elbowportion 126 and/or base portion 124) outwardly relative to support 110,causing the arms 120 to pivot about base portion 124 so as to urge tipportions 122 toward the outer surface 110S. This may direct tip portions122 more securely toward the annulus A, and may enhance compression ofthe leaflets between the arms 120 and the outer surface 110S of thesupport 110.

As shown in FIG. 2F, the apparatus 100 may further comprise a valve 150mounted in the interior lumen of the support 110. The valve 150 maycomprise a temporary or permanent valve adapted to block blood flow inthe upstream direction and allow blood flow in the downstream directionthrough the support 110. The valve 150 can have a plurality of leaflets152, and may be formed of various flexible and impermeable materialsincluding PTFE, Dacron, or biologic tissue such as pericardial tissue orxenograft valve tissue such as porcine heart tissue. Other aspects ofvalve 150 are described further below. An internal wall within the lumenof the support 110 can be covered at least partially by an impermeablecover 151 to prevent blood flow from inside the support 110 to theoutside of the support 110, where it could leak around the exterior ofthe support 110. In another embodiment the cover 151 may be affixed toan exterior wall of the support 110 and, in either embodiment, may beintegrally formed with or attached directly to valve 150. In anadditional embodiment, a cover 151 can be applied on at least portionsof both the inside wall and outside wall of the support 110.

In some embodiments, the apparatus 100 may comprise a membrane orsealing members 160 extending radially outward from the outer surface110S of the support 110 to inhibit blood flow between the support 110and the native leaflets. For example, the sealing members may extendoutward from the support 110 so as to extend along the long dimension ofthe mitral valve into the native commissural regions 170, as shown inFIG. 2F. The sealing members 160 may comprise any of a number offlexible, blood-impermeable biocompatible materials, including one ormore of a polymer, thermoplastic, polymer, a polyester, a syntheticfiber, a fiber, polyethylene terephthalate (hereinafter “PET”), PTFE orDacron™. In one embodiment, the sealing members 160 can extend radiallyoutward from the support 110 in a direction extending along a longdimension of the annulus so as to inhibit flow blood flow between theleaflets outside of support 110 when the plurality of arms 120 arecoupled to peak portions of the annulus. The sealing members 160 may beconfigured to pass between the leaflets so as to cover the line ofcoaptation on the downstream side of the valve (e.g., ventricular sideof the mitral valve), thereby inhibiting the flow of blood in anupstream direction (from the ventricle to the atrium in the case of themitral valve). The sealing members 160 can alternatively be coupled toone or more of the arms 120. For example, the sealing members 160 may becollapsed or wrapped around the tip portions 122 of one or more arms 120during delivery of the apparatus 100, and the sealing members 160 mayopen or become unfurled and urged against the lower surface of theleaflets by the pressure and flow of blood when the arms 120 are inposition behind the leaflets. In a particular example, the sealingmembers 160 may be coupled to the outermost arms 120 in each row 128 soas to be positioned near the native commissural regions 170 when thearms 120 are in the outward configuration 123. Thus, when the sealingmembers 160 are deployed, they can extend over the native commissuralregions 170 and can inhibit or prevent the flow of blood through thenative commissural regions 170 in either the upstream or down streamdirections.

FIGS. 2F1-A and 2F1-B are side and top views, respectively, of aprosthetic heart valve device (e.g., apparatus 100) having sealingmembers 160 configured to be positioned adjacent the commissures of thenative valve. In some embodiments of the apparatus 100 suitable formitral valve replacement, a pair of sealing members 160A, 160B may becoupled to opposing sides of the support 110, e.g., roughly 90 degreesoffset from the locations of rows 128A, 128B of arms 120, and so as tobe positionable in the commissures of the native valve. Sealing members160A, 160B may comprise tent-like conical or pyramidal tubes of amembrane or fabric such as Dacron or PTFE, tapering from an opendownstream end 161 to a closed, narrow upstream end 162. The outersurface 110S of the support 110 (or alternatively, an inner surface ofthe support 110) may be covered with an impermeable fabric to preventblood flowing from within the sealing members into the interior of thesupport 110. Wires may be sewn into sleeves along the edges and alongthe longitudinal peaks of the sealing members 160A, 160B to maintaintheir shape and conformity. The sealing members 160A, 160B areconfigured to fit adjacent or within commissures between the posteriorand anterior leaflets, to effectively seal the outer surfaces of thesealing members 160A, 160B to the native valve tissue. During systole,blood is pushed under pressure though the open downstream end 161 of thesealing members 160A, 160B thereby inflating the sealing member 160A,160B and urging it against the native leaflets and enhancing the seal.Optionally, openings (not shown) may be provided between the interior ofthe sealing members 160A, 160B and the interior of the support 110,allowing blood to flow from within the support 110 into the interior ofthe sealing members 160A, 160B to further pressurized them.

In addition to the commissures, gaps may be present between the leafletsand support 110 in other areas around the circumference of the support110 and through which perivalvular leaks may occur. A sealing member 160or other similar membrane feature can be included to extend around mostor the entire circumference of the support 110 so as to seal any suchgaps. In one embodiment, shown in FIGS. 2F2-A and 2F2-B, a bell-shapedskirt 163, tapering from an open downstream end 164 to a closed,narrower upstream end 165 can be provided on the apparatus 100. Theskirt 163 may be integrally formed with or sewn to a cover 166 (such ascover 151 discussed above with respect to FIG. 2F) over the interiorwall of the support 110. In some embodiments, the skirt is baggy, orotherwise provided with extra membrane material, and can be veryflexible and conformable so as to conform to the shape of any gapsbetween the leaflets and the support 110. In some embodiments, the skirt163 can be configured to be expanded or inflated by blood during systoleso as to be urged radially outward to fill in any such gaps. Inoperation, and during systole, blood is forced through the opendownstream end 164 so as to radially expand the skirt 163 into firm andcontinuous engagement with the leaflets. Openings (not shown) may beprovided in the wall of the support 110 and/or in the cover 166 therebyproviding fluid communication with an interior of the skirt 163 to allowblood to flow from the interior lumen of the support 110 to the interiorof the skirt 163 to further pressurize the skirt. Optionally, the skirt164 may be tacked or tethered to the support 110 at one or morelocations around the perimeter of the support and/or the narrowerupstream end 165 of the skirt 163 to limit the radial expansion oreversion of the skirt 163 (e.g. via sutures 167 shown in FIG. 2F2-B).Additionally, wires (not shown) may be sewn in or otherwise coupled tothe material of the skirt 164 to keep the downstream end 164 open and/orotherwise maintain the skirt's desirable shape. As a further option, theskirt 163 may include plaits or internal partitions dividing the skirt163 into a series of vertical tubular sections around the circumferenceof the support 110.

In alternative embodiments, the skirt 163 may extend only part-way downthe length of the support 110 from the upstream end 112 a, as shown inFIG. 2F3-A. In another arrangement, shown in FIG. 2F3-B, the skirt 163can be attached to the support 110 at the upstream end 112 a andconfigured to flare outwardly in an upstream direction (e.g., have anopen skirt end facing upstream). In further embodiments, the skirt 163may attach to an extend from the downstream end 114 a of the support110, flaring and opening either in a downstream direction as shown inFIG. 2F4-A, or flaring and opening in an upstream direction as shown inFIG. 2F4-B. In another embodiment, the skirt 163 may flare in theupstream direction while extending around the outside of arms 120, asshown in FIG. 2F4-C. The skirt 163 may alternatively be mounted to thesupport 110 in a mid portion, between the upstream and downstream ends112 a, 114 a. In further embodiments, the skirt 163 may also extendaround only a subsection of the perimeter of the support 110.

In a further embodiment, shown in FIGS. 2F5A-2F5D, one or more leafletpushers 300 can be coupled to the support 110 and configured to extendin the upstream direction of engage the leaflets and urge them intocoaptation with each other or into sealing engagement with the outersurface 110S of the support 110. The leaflet pushers 300 may beconstructed similarly to arms 120 but because they need not serve thefunction of pushing against or pressing into the annulus to anchor thedevice 100, leaflet pushers 300 may, in some embodiments, have lessrigidity and strength as arms 120. Further, in select embodiments,leaflet pushers 300 can have further lateral extension when comparedwith arms 120 to enable the pushers 300 to engage the leaflets near thevalve commissures, (e.g., where the leaflets are not in engagement withthe support 110 and may be prevented from coapting). As shown in FIGS.2F5A-2F5D and described further below, the leaflet pushers 300 can pushin opposing directions so as to urge the leaflets toward each other.

As shown in FIGS. 2F5A-2F5D, leaflet pushers 300 extend from adownstream end 114 a of support 110. A pair of leaflet pushers 300 canbe provided and coupled on each of two opposing sides of the support 100which can be approximately 90 degrees offset from the two opposing setsof arms 120, such that each pair of leaflet pushers 300 are positionedto extend toward the commissural regions 170 of the valve. In oneembodiment, each pair of leaflet pushers 300 can be arranged in acrossing pattern along the outer surface 110S of the support such thatthe distal tips 302 are on opposite sides from the bases 304 (shown inFIGS. 2F5B and 2F5D). When the support 110 is in the radially-contracteddelivery configuration 111, distal tips 302 are separated from eachother as shown in FIGS. 2F5A-2F5B. In this configuration, leafletpushers 300 can be positioned behind the leaflets L such that the distaltips 302 engage the ventricular or downstream side of the leafletsoutside of the support 110. When the support 110 is expanded to itsexpanded configuration 113, distal tips 302 are urged toward oneanother, pushing the leaflets L toward each other into sealedcoaptation, as shown in FIGS. 2F5C-2F5D. Alternatively or additionally,leaflet pushers 300 may be configured to push leaflets L toward thesupport 110 so as to seal against the outer surface 110S of the support110.

FIG. 2G is a schematic illustration of a side view of a prosthetic heartvalve device (such as apparatus 100) having a support 110 shown in anextended configuration 113 and having a plurality of arms 120 in anoutward configuration 123 extending between chordae tendineae CT. In avariety of embodiments, the locations and geometry of the plurality ofarms 120 are configured so the arms 120 pass unobstructed between thechordae tendineae CT. For mitral valve replacement, the plurality ofarms 120 can be arranged to pass more easily behind the anterior andposterior leaflets. In many embodiments, the tip portions 122 of thearms 120 extend in the outward configuration 123 along two rows(previously described as rows 128A and 128B). The plurality of tipportions 122 in each row can be spaced at distance within a range fromabout 2 mm to about 7 mm away from the outer surface 110S when thesupport 110 is in the delivery configuration 111. These tip portions 122could then be passed relatively easily behind the anterior and posteriorleaflets near a middle portion of the native leaflet, where there arerelatively few chordae. The tip portions 122 can be relatively closer tothe outer surface 110S and the bend radius of the curved elbow portion126 about axis 126A near the bottom of the arm 120 can be smaller forthe arms 120 near the second midline 110M2 of the support 110 than forthe arms 120 further away from the second midline 110M2. Prior toexpansion of the support 110 from the delivery configuration 111 toexpanded configuration 113, the arms 120 may hold or engage the centralportions of the anterior and posterior leaflets together against theouter surface 110S of the support 110. In some embodiments, this gentletemporary constraint of the leaflets may inhibit pressure gradientsand/or regurgitation during the implantation procedure.

For mitral valve treatment, during expansion of the support 100 into theexpanded configuration 113, one row of the arms 120 can be configuredfor placement behind the anterior leaflet and to contact the annuluswithout extending excessively or obstructively into the left ventricularoutflow tract. The other row of arms 120 can be configured forpositioning behind the posterior leaflet and may contact regions of theventricular wall, while engaging the posterior annulus with the tipportion 122. The more laterally positioned arms 120—those further awayfrom the midline 110M2 in each row—may remain more millimeters away fromthe outer surface 110S of the support 110 when the support has beenexpanded, so that the tip portions 122 can make contact with the annuluseven though the expanded support 110 does not fill the entire area ofthe native mitral valve near the commissures 170. These more laterallypositioned arms 120 may also engage the leaflets and urge them againstthe support 110 and in closer apposition to each other to help preventretrograde blood flow through the commissures 170.

In some arrangements, this approach may tend to push some or all of thecentral chordae CT laterally. Accordingly it may be desirable in someembodiments to make the arms 120 a little longer, so that the arms 120extend in the downstream direction further into the left ventricle(e.g., increase the distance 138 shown in FIG. 2A1) and so that thechordae CT and leaflets are more minimally displaced. The leaflets canbe compressed by the arms 120 an amount sufficient so as to providesupport, keep the leaflets out of the way of the prosthetic valve 100,and to limit systolic anterior motion.

Referring again to FIG. 2A1, the skeleton 140 of the support 110 maycomprise a plurality of nodes 110N which move apart from one anotherwhen the skeleton 140 is expanded. The base portions 124 of the arm 120can be coupled to the plurality of nodes 110N such that the plurality ofarms 120 separate from one another when the support 110 expands from thedelivery configuration 11 to the expanded configuration 113. Theplurality of bases 124 can be coupled to the plurality of nodes 110N,for example, such that the plurality of base portions 124 separates withrespect to each other when the support 110 expands. The arms 120 and tipportions 122 may also splay outwardly—i.e. the splay angle 127SA of thearms 120 relative to the longitudinal axis 110A may increase—when thesupport 110 expands from the delivery configuration 111 to the expandedconfiguration 113. Each of the plurality of base portions 124 may beintegrally formed with the nodes 110N or can be connected to theplurality of nodes 110N in other ways, for example, by welding, bonding,mechanical fastener, slider, tube, and many attachment and othercoupling mechanisms known in the art so as to transmit forces from thetip portions 122 to the skeleton 140 of the support 110.

In some configurations, due to their angle relative to the support 110,arms 120 may translate forces downward and radially inward against thesupport 110 at the location (e.g., base portion 124) where the arms 120are coupled to the support 110. This force may be at a maximum forcewhen a valve (e.g., valve 150) mounted to the support 110 closes and theforce of blood pressure downstream of the valve 150 pushes the support110 in the upstream direction and arms 120 engage the annulus.Accordingly, the support 110 may have a hoop strength sufficient toresist inward radial deformation at the point where the arms 120 arecoupled to the support 110.

In one embodiment, the support 110 may include a retention structure toinhibit migration of apparatus 100 in the downstream direction. Inembodiments suitable for mitral valve replacement, the retentionstructure may be coupled to support 110 on or near its upstream end 112a so as to be located in the left atrium and upstream of the nativeannulus. FIG. 2H-1 is an isometric side view of a prosthetic heart valvedevice (such as apparatus 100) having a flange 165 extending outwardlyfrom the support 110 at a proximal, upstream end 112 a, in accordancewith another embodiment of the present disclosure. The flange 165 can becoupled to the support 110 and externally oriented so as to extendlaterally from the upstream portion 112 of the support 110 and have acircumference greater than the circumference of the support 110. Thepositioning of the flange 165 can be upstream of the annulus to inhibitmigration of the apparatus 100 downstream through the native annulusduring contraction of the upstream or first heart chamber. The flange165 may be integrally formed with the support 110 or a separatecomponent coupled to the support 110, and can be made of the same ordifferent material as the support 110, e.g. a balloon-expandablemalleable material such as stainless steel, or a self-expanding materialsuch as nitinol. In some embodiments, the flange 165 may comprise anintegral part of the skeleton 140 of the support 110. In alternativeembodiments, the flange 165 can be attached to the support 110 in avariety of ways such as by sutures, clips, or other fasteners known inthe art. The flange 165 can have an outer diameter which is about 2-20mm larger than the outer diameter of the support 110 so to extendoutwardly and over the native annulus within the first heart chamber.The flange 165 can include a cover (not shown) such as polyester,expanded PTFE, or other material to encourage tissue in-growth. Theflange 165 can be spaced apart from the tip portions 122 of arms 120 inthe upstream direction at a distance large enough to position theannulus between the tip portions 122 and the flange 165, and in someembodiments, to compress the annulus between the tip portions 122 andthe flange 165 to hold the apparatus 100 in position relative to thenative valve. Accordingly, in some embodiments, the flange 165 can beconfigured to extend from the upstream portion 112 of the support 110and engage a supra-annular surface while the arms 120 extend from thedownstream portion 114 of the support and extend outwardly in anupstream direction to engage a subannular surface, thereby securing theapparatus 100 to the native valve region.

In another embodiment, as shown in FIG. 2H-2, a plurality of elongatedfingers 165PF may extend radially outward from the upstream end 112 a ofthe support 110. The fingers 165 PF may be configured to be deflectableinto a straightened configuration for delivery within the lumen of acatheter, and to have sufficient resiliency to return to the radiallyextended configuration when released from the catheter. In someembodiments, the fingers 165 PF may be coupled to or comprise extensionsof the arms 120. For example, as shown in FIG. 2H-2, rather thanterminating at the point of attachment to support 110, arms 120 mayextend upwardly from curved elbow portions 126 in an upstream directionalong the outer surface 110S of the support 110 to the upstream end 112a, and may then be bent outwardly so as to extend radially away from thesupport 110 a distance sufficient to provide retention for the apparatus100 within the upstream or first heart chamber.

The embodiments described herein can also be adapted for trans-apicaldelivery via ventricular incision or puncture, or retrograde deliveryvia the aorta. In trans-apical and aortic delivery, due to the approachcoming from the downstream side of the valve rather than the upstreamside, the upstream portion 112 and the downstream portion 114 of theapparatus will be reversed on the delivery system, and the deliverysystem can be modified appropriately.

FIG. 2I shows a prosthetic treatment apparatus 100 adapted to treat theaortic valve AV in accordance with other embodiments of the presenttechnology. The shape, size, stiffness, and other aspects of support 110and arms 120 can be adapted as needed for the aortic valve. For aorticvalves, it may be preferable to group the tips 122 of the arms 120 intothree groups in the outward configuration 123 so as to correspond to thetricuspid native aortic valve, or, in other embodiments, in two groupswhen bicuspid aortic valves are treated. Alternatively, the plurality ofarms 120 may be evenly spaced about the circumference of the support110. When placed in the aortic valve AV, in addition to anchoring theapparatus 100 in position by engagement with the annulus, the arms 120may help to ensure that the valve is placed at the right longitudinallocation in the aorta, for example, as far upstream as possible to avoidblockage of the coronary ostia. Any of the embodiments described hereinor particular features thereof may be utilized in embodiments configuredfor aortic valve treatment.

Because the apparatus 100 utilizes the plurality of arms 120 to engagethe annulus for maintaining the position of the apparatus 100 ratherthan outward compression against the aortic wall, the support 110 can beexpanded to a diameter slightly smaller than the inner diameter of theaorta. This slightly undersized expanded configuration 113 may protectagainst unintentional blockage of the coronary ostia. Further, thepresent technology may provide more consistent and complete deploymentof the apparatus 100 than prior transcatheter aortic valves that rely onaggressive expansion against the aortic wall and/or annulus. Priortranscatheter aortic valves may deploy to a non-circular, uneven shapebecause of calcium nodules in the native valve leaflets. In contrast,the apparatus 100 of the present technology can be deployed consistentlyinto a known shape and size in which it will reliably function. Thisimproved coupling to the annulus can help to prevent perivalvularleakage as well as incompetent valve closure due to incomplete valveexpansion. Further, the plurality of arms 120 can hold the native aorticleaflets against the support 110, helping to decrease perivalvularleakage and regurgitation. The improved coupling to the annulus with thearms 120 and the support 110, as described herein, may also reduce theincidence of embolic debris and stroke, which can be a particularconcern with transcatheter aortic valve replacement.

FIG. 2J is a top view of a prosthetic heart valve device (such asapparatus 100) having a plurality of sealing members 160 configured toextend toward tricuspid valve commissures of the native aortic valve asopposed to the bicuspid valve commissures of a native mitral valve. Thesealing members 160 are positioned around the support 110 (shown in theexpanded configuration 113) and configured to extend into, over, orunder tricuspid (e.g. aortic) valve commissures, so as to reduce therisk of regurgitation or perivalvular leaks. In the illustratedembodiment, the sealing members 160 may include three separate portionsangularly offset by about 120 degrees to as to extend into each of thethree aortic commissures. In other embodiments, the sealing members 160may have a triangular configuration, so that the corners of thetriangles extend towards the native tricuspid valve commissures.

Devices suitable for aortic deployment may further include a flange 165or plurality of fingers 165PF on the upstream end 112 a of the support110 (similar to those shown in FIGS. 2H-1 and 2H-2) that may bepositioned on the ventricular side of the aortic annulus to help inhibitor prevent downstream movement of the apparatus 100.

Additionally, devices suitable for aortic valve replacement may beimplanted using either a retrograde approach via the aorta, atrans-septal approach from the right atrium, or transapical approach viaa puncture or incision in the left ventricle. In retrograde approaches,because the native valve will be approached from the downstream siderather than the upstream side, the apparatus 100 will be oriented in areverse direction on the delivery system from the trans-septal mitralembodiments described above. Further, the delivery system can bemodified appropriately for this reverse orientation. In apicalapproaches, the device will be oriented similarly to trans-septal mitralembodiments, although because of the shorter length and surgicalapproach, other suitable modifications may be made to the deliverysystem.

FIG. 3A is an isometric view of a prosthetic heart valve device havingan expandable support 110 shown in a delivery configuration 111 andhaving a plurality of arms 120 shown in an inward configuration 121 suchthat the device is suitable to access a valve of the bodypercutaneously. FIGS. 3B, 3C and 3D show front, side, and top views,respectively, of the expandable support 110 and plurality of arms 120configured as in FIG. 3A. Each of the plurality of arms 120 can deflectlaterally in response to tissue contact. In some embodiments, the height138 of the tip portions 122 and/or the length of arms 120 can vary inresponse to tissue contact with the annulus. Many of the structures aresimilar to the embodiments of FIGS. 2A-2J and identical numbers andletters may indicate similar elements.

Referring to FIGS. 3A-3D together, the skeleton 140 comprises a strutpattern geometry. The plurality of struts 142 extends between aplurality of elongate posts 144. The plurality of struts 142 can extendbetween the posts 144 in a sinusoidal configuration which can becollapsed so as to decrease the separation distance between the ends ofeach strut 142 and to decrease the separation distance between each ofthe posts 144 when the support 110 is radially contracted in thedelivery configuration 111. The posts 144 may comprise substantiallyrigid structures and can extend substantially parallel to thelongitudinal axis 110A so as to transfer the load of the valve 150 tothe plurality of arms 120. The plurality of struts 142 can be attachedto the plurality of posts 144 so as to define the plurality of nodes110N.

With expansion of the support 110 from the delivery configuration 111 tothe expanded configuration 113, the struts 142 can assume an elongateconfiguration so as to increase the separation distance of the posts 144and corresponding nodes 110N. The distance between the ends of thestruts 142 can be increased with deformation of the struts 142 withforce of a balloon (not shown), or the struts 142 may comprise a shapememory material, for example. The skeleton 140 may also comprise avariety of eyelets, hooks, or other features to facilitate attachment ofthe valve, membrane, sealing member, skirt, cover or other elements.

The plurality of tips 122 can be curved such that each tip comprises acurved portion 122C. The curved portion 122C of each of the plurality oftips 122 can be curved around an axis 122CA. The curved portion 122C canextend from the extension portion 127 pointing inwardly toward thesurface 110S of the support 110, and the axis 122CA of each curvedportion may be parallel to a tangent of the outer surface of support110, or, alternatively, parallel to the midline 110M1, for example. Inthe embodiment shown, the axis 122Ca of each curved portion 122C aregenerally parallel to each other and parallel to midline 110M1.

The plurality of arms 120 are attached to the downstream ends of posts144 and have a curved elbow portion 126 extending a distance 139 belowthe downstream end portion 114 of the support 110. Each curved elbowportion 126 can be curved about an axis 126 which, like axis 122CA, isparallel to midline 110M1. Alternatively, axis 126A may be parallel to atangent of the outer surface of support 110, or disposed at some otherangle. Intermediate elbow portions 126 may comprise a cam portion 126Cto engage the balloon (not shown). The curved elbow portion 126 maycomprise U-shaped portion 126U. The curved elbow portion 126 can extendto the extension portion 127, and the extension portion 127 can extendfrom the curve elbow portion 126 to the tip portion 122.

FIG. 3E is an isometric view of a prosthetic heart valve device (such asapparatus 100) having an expandable support 110 shown in the deliveryconfiguration 111 and a plurality of arms shown in the outwardconfiguration 123 such that the arms 120 are positioned to receivedleaflets of a native valve between the arms 120 and the expandablesupport 110. FIGS. 3F, 3G and 3H show front, side, and top views,respectively, of the expandable support 110 and plurality of arms 120configured as in FIG. 3E.

FIG. 3I is an isometric view of a prosthetic heart valve device (such asapparatus 200) having an expandable support 110 shown in an expandedconfiguration 113 and a plurality of arms 120 shown in the outwardconfiguration 123 such that the device is suitable to couple to theannulus of a native valve. FIGS. 3J, 3K and 3L show front, side, and topviews, respectively, of the expandable support 110 and plurality of arms120 configured as in FIG. 3I. The plurality of struts 142 comprises anelongate configuration to increase the separation distance among posts144, and the ends 143 of the struts 142 are spaced farther apart fromeach other. The nodes 110N between posts 144 are spaced farther apartfrom each other and correspond to the increased separation distancebetween posts 144. The posts 144 comprise sufficient rigidity totransfer the load of the valve 150 to the plurality of arms 120. Thestruts 142 extending between the posts 144 comprise sufficient strengthto support the load forces of the arms 120.

FIG. 3I1 is a force diagram illustrating the forces exerted on the armsduring systole and showing the corresponding forces to the support'sstruts 142 and posts 144. In some embodiments, when engaging theannulus, the arms 120 are oriented so as to be generally orthogonal to,or at an oblique angles between about 45 and 135 degrees relative to,the subannular surface, such that the loading exerted upon the arms 120is primarily a compressive, axial load. Assuming for simplicity that theforce through each arm 120 is entirely axial, due to the angle of thearm 120 relative to the support 110, the force 120F exerted on each arm120 results in a radially inward force 142F to the support 110 and anaxial force 144F to the support 110. Each of the posts 144 attached tothe arm 120 comprises sufficient strength to support the arm 120 inresponse to axial force 144F, and the struts 142 coupled to each posts144 near the downstream end 114 a comprise sufficient strength to resistdeformation between the ends 143 and support the arm 120 in response tothe radial force 142F.

FIGS. 4A and 4B are side views of prosthetic heart valve devices(apparatus 100) having a plurality of arms 120 shown in a first inwardconfiguration 121 (FIG. 4A) and an outward configuration 123 (FIG. 4B).In one embodiment, apparatus 100 comprises a self-expanding support 110composed of a resilient material configured to self-expand from thedelivery configuration shown in FIG. 4A to the expanded configurationshown in FIG. 4B. The material may include a variety of different metalsor polymers, but in some embodiments, includes a super-elastic materialsuch as Nitinol. A plurality of arms 120 are coupled to the support 110and have an inward configuration 121 and an outward configuration 123.The arms 120 may be slidably coupled to the support 110 such that theheight 138 of each of the plurality of tip portion 122 along the axis110A can vary relative to the support 110 and relative to each other tipportion 122. In some embodiments, the arms 120 may comprise an upperportion 129 that extends along the support 110 to vary the height of thearm 120 relative to the support 110. The upper portion 129 may be woventhrough the openings in the outer surface 110S of the support 110, ormay extend through a slidable coupling such as a tube (not shown)mounted to the support 110, for example. The tip portion 122 of each ofthe plurality of arms 120 may include a pressure reducing tip portion122PR, having for example a curve or loop to inhibit tissue penetration.The self-expanding support 110 may or may not have struts (not shown) tofacilitate attachment of a replacement valve structure.

Operatively, when the pressure reducing tip portions 122PR engageannulus tissue, the arms 120 can slide axially in the downstreamdirection relative to support 110 to accommodate the varying elevationsof the annulus and to ensure that all of the arms 120 contact theannulus. The pressure reducing tip portions 122PR of the arm 120 mayalso be configured to deflect when contacting annulus tissue to avoidtrauma and to allow further variation of the height of the pressurereducing tip portions 122PR. Preferably arms 120 are slidably coupled tothe support 110 in such a way that their axial position is maintainedonce the support 110 is positioned in the desired final location. Forexample, the coupling mechanism may apply significant friction to thearms 120 such that a fairly high threshold axial force must be appliedto the arms 120 to overcome such friction. For example, the thresholdforce could be of sufficient magnitude that the user could apply it viathe delivery system, but could be higher than the forces applied to thearms 120 once implanted. Alternatively, the arms 120 may have teeth,bumps, notches, detents, or other mechanical indexing features thatengage a cooperating structure coupled to the support, providing aseries of axial positions at which the arm 120 can be maintained.

FIGS. 5A1-5A4 are side views of a prosthetic heart valve (such asapparatus 100) having arms 120 with rings tips 122 configured inaccordance with another embodiment of the present technology. Theapparatus 100 is shown having a plurality of arms 120 with pressurereducing tip portions 122PR comprising rings or loops wherein each ring122 can lie in a vertical plane extending radially from the centrallongitudinal axis 110A of the support 110, or which is parallel to atangent of the outer surface 110S of the support 110. In such anarrangement, the tangential orientation of the ring 122 may improve theease of compressing the arms 120 to form a compact delivery profile. Inother embodiments, the ring 122 can be at various other angles relativeto the support 110. The support 110 in the delivery configuration 111may comprise a cross-sectional diameter 111D defined by a first outerboundary 111B1 and a second outer boundary 111B2. The curved portion 126of the arms 120 may have one or more bends 126B1, 126B2, 126B3 so as tooffset the axis 126A (FIG. 5A4) to within the outer boundaries 111B1 and111B2 of the profile of the support 110.

FIGS. 5A5-5A6A show a further embodiment of a prosthetic heart valvedevice (apparatus 100), having arms 120 with a first, flattenedcross-sectional dimension and a second, elongated cross-sectionaldimension such that the arms 120 have a relative resistance to bendingin different directions. FIG. 5A6B shows a portion of the arm 120 alongline A-A of FIG. 5A5. For example, curved portions 126 of the arms 120can have a cross-sectional shape 126CSA, as shown in FIG. 5A6A. Thecross-sectional shape 126CSA is flattened and wider along a distance126CSC in the circumferential direction (parallel to a tangent of theouter surface 110S of support 110) and relatively thin along a distance126CSR in the radial direction. Accordingly, the cross-sectionaldistance 26CSC extending circumferentially and parallel to the support110 is greater than the cross-sectional distance 126CSR extendingradially. This arrangement can give the arms 120 a lower bendingstiffness toward and away from the support 110, but a relatively highbending stiffness in a circumferential direction. Various othercross-sectional dimensions and geometries may be selected to provide adesirable relative bending stiffness in any direction.

FIG. 5A6B shows a portion of the arm along line B-B of FIG. 5A5. Asillustrated, the extension portion 127 of each arm 120 can have adifferent cross-sectional shape than the curved elbow portion 126 of thearm 120 (FIG. 5A6A). For example, while the cross sectional shape 127CSAis flattened and wider along a distance 127CSC in the circumferentialdirection (parallel to a tangent of the outer surface 110S of support110) and relatively thin along a distance 127CSR in the radial direction(similar to the cross-sectional shape 126CSA), the radial dimensionalong distance 127CSR can be larger than the radial dimension alongdistance 126CSR in the curved elbow portion 126 in order to resistbuckling of the extension portions 1127. The flattened and widerdimension 27CSC can provide a wider surface for engagement of the nativeleaflets.

In other embodiments, the curved elbow portion 126 may have a radialdimension 126CSR that is the same or greater than that of the extensionportion 127 so as to have greater resistance to bending. Further, eitherthe curved elbow portion 126 or the extension portion 127 may have across-section in which the circumferential dimension is closer to orabout the same as the radial dimension, giving it more rigidity andresistance to bending away from the support 110. In one embodiment, thecurved elbow portion 126 may have a cross-sectional shape 126CSA whichis circular, while the extension portion 127 has a cross-sectional shape127CSC that has polygonal geometry, e.g. rectangular, trapezoidal,triangular or other shape.

FIGS. 5A7-5A8 are side and front views, respectively, of prostheticheart valve devices (apparatus 100) with arms 120 including arm tipshaving a pressure reducing bent tip portion 122 PR for providing aplanar subannular interfacing tip. As shown, arm tip portions 122 havean approximately 90° bend 122C1 about a horizontal axis so that theloops of the pressure reducing tip portions 122PR lie in a planegenerally parallel to the subannular plane of the native valve. In someembodiments, the pressure reducing tip portions 122PR may be bentoutwardly away from the support 110 as shown in FIG. 5A7, inwardlytoward the support 110 as shown in FIG. 5A8, or laterally in acircumferential direction (not shown).

FIGS. 5A9-5A10 are partial side views of a prosthetic heart valve device(apparatus 100) having an arm 120 with loop 510 and two supportattachment points on a support 110. As shown, the arms 120 can comprisea loop 510 such as a wire loop with both ends of loop 510 coupled tosupport 110 to provide a pressure reducing tip 122PR at a distal end ofthe loop 510. The distal looped end of the loop 510 may be formed invarious configurations, with the loop lying in a vertical plane as shownin FIG. 5A9, in a horizontal plane, or in various other configurations.A plurality of such loops 510 may be coupled to the support 110 invarious arrangements as described elsewhere herein. In some embodimentsand as shown in FIG. 5A10, in order to reduce a cross-sectional profileduring delivery, wire loops 510 may be configured to wrap helicallyaround of the exterior of the support skeleton 140 in an inwardconfiguration 121 of the arm 120.

As described above, the support 110 and arms 120 can be coveredpartially or entirely with a coating or covering which promotes tissuein-growth and provides additional sealing within and around the device.In some embodiments, the arms 110 and the support 110 can be covered byor contained within a fabric cover of Dacron™, ePTFE, or other suitablematerial. Various arrangements of suitable covers are illustrated inFIGS. 5A11-5A15. In some embodiments, more than one arm 120 (e.g., aplurality of arms 120) may be contained together within a single covermember as described below. For example, in the embodiment shown in FIG.5A11, a first plurality of arms 120 on a first side 110S1 of the support110 can be contained within a first cover member 320, while a secondplurality of arms 120 on a second side 110S2 of the support 110 can becontained within a second cover member 322. Cover members 320, 322 maycomprise a single sheet or wall of material extending across and adheredto one surface of the arms 120, or they may be sewn or otherwise madeinto a hollow sock or mitten which fits over the arms 120 and completelysurrounds them. Cover members 320, 322 may be integrally formed with orattached to a tubular cover or sleeve 324 which extends around theexterior and/or interior of support 110. Cover members 320, 322 may eachcontain all of the arms 120 on the respective sides of support 110, oronly a selected portion of the arms 120.

In another embodiment, shown in FIG. 5A12, two or more arms 120 can eachbe covered by a separate cover member 326, however, the cover members326 are interconnected at the distal ends of arms 120 by aninterconnecting portion 328. The cover members 326 may form a continuoustubular member extending over the two or more arms 120, or, in anotherembodiment, separate tubular members 326 may cover each arm 120 and aninterconnecting piece may be attached to the distal end of each tubularmember. In some embodiments, the interconnection of two or more arms 120by the cover member 326 and portion 328 may distribute forces morebroadly across the valve annulus as well as reducing trauma to theannulus tissue.

In yet another embodiment, shown in FIG. 5A13, each arm can be coveredby a separate tubular cover member 330. As described with respect toFIG. 5A11, each cover member 330 may be integrally formed with orcoupled to a tubular sleeve 332 configured to cover the support 110. Adistal cap 334 of each cover member 330 may conform to the shape of theunderlying arm 120 and tip portion 122. Alternatively, the distal cap334 may have a configuration which distributes force, reduces pressure,and/or reduces the trauma exerted by engagement of the arm 120 on theannulus. For example, as shown in FIG. 5A14, the distal cap 334 maycomprise a generally spherical projection 336 substantially larger thanthe area of tip portion 122. Projection 336 may be soft and padded so asto minimize trauma to the annulus tissue, and made of a material whichenhances friction against the annulus to minimize movement of the arm120 against the tissue. Further, each cover member 330 may be movablelongitudinally relative to the underlying arm 120 to allow forself-adjustment of position of the projection 336, thus accommodatingfor varying elevation of the valve annulus. For example projection 336may have an inner pocket 339 for receiving the arm 120 and/or tipportion 122 which, prior to deployment of the device, extends toward adistal tip 338 further than does arm 120, leaving some vacant roomdistally of the tip portion 122. When projection 336 is brought intoengagement with the annulus, it may be pushed downward relative to thearm 120 due to the flexibility and compressibility of the cover member330 and/or projection 336, thereby acting as a shock absorber andensuring engagement of each distal tip 338 with the annulus despitevariations in the elevation of the subannular surface.

In a further embodiment, shown in FIG. 5A15, the tip portion 122 of arm120 is covered by a cover member 340. Cover member 340 may comprise afabric sock-like covering having a teardrop shape and adapted tosurround and adhere to a distal portion of the arm 120 (including thetip portion 122). Alternatively, the tip portion 122 may itself beformed in a teardrop shape, and a separate cover member 340 may becorrespondingly shaped so as fit over the tip portion 122. The covermember 340 may cover only the tear-dropped end of the arm 120, or maycover a larger portion of the arm 120, or in some embodiments, cover theentire arm 120.

FIGS. 6A1 to 6B4 are bottom, front, side and isometric views ofprosthetic heart valve devices (apparatus 100) showing arms 120 thatcross from a support attachment site on a first site 110S1 of a support110 to a leaflet and/or annulus engaging site oriented on a second site110S2 of the support 110 opposite the first side 110S1. In oneembodiment, each of the plurality of arms 120 comprises a curved elbowportion 126 configured to span across a downstream portion 114 thesupport 110 and extend from the first side 110S1 to the second side110S2. Accordingly, the base portion 124 of arm 120 can be coupled to adifferent side (e.g., side 110S1) of the support 110 than that on whichthe tip portion 122 is positioned (e.g., side 110S2). The arms 120 maybe constructed like any of the various other embodiments describedherein, including single wires or ribbons with looped tips as shown inFIGS. 6A1-6A4, or in complete loops as shown in FIGS. 6B1-6B4. Uponexpansion of the support 110, the arms 120 pull the native leafletstoward each other and/or toward the outer surface 110S of the support110, thereby enhancing the sealing of the leaflets against the support110 to prevent perivalvular leaks.

FIG. 7A is a top view of a prosthetic heart valve device (apparatus 100)having an expanded support 110, with optional sealing members 160 (shownin dotted lines) and with arms 120 and having a prosthetic valve 180retained and positioned inside the expanded support 110. In oneembodiment, the prosthetic valve 180 can be placed inside the expandablesupport 110 when the expandable support 110 is in the expandedconfiguration 113 and after it has been implanted at the native valvelocation. The support 110 can be expanded from the deliveryconfiguration 111 to an expanded configuration 113 at the native valvelocation without a valve contained within the support (as shown), orwith a temporary valve 185 coupled inside the expandable support (asshown in FIG. 7B). The prosthetic valve 180 can be positionedtransvascularly into the support 110 and implanted or retained within alumen of the support 110. Operatively, the prosthetic valve 180 can bedelivered by catheter and placed inside the support 110 in a deliveryconfiguration, and expanded radially outward as indicated with arrows182, for example.

FIG. 7A1 shows a prosthetic valve 180 in an expanded configuration foruse with the support 110. The prosthetic valve 180 may comprise acommercially available valve, such as, for example, the Sapien™transcatheter heart valve from Edwards LifeSciences LLC or theCoreValve™ transcatheter heart valve from Medtronic, Inc. The prostheticvalve 180 may comprise an expandable stent-like frame 184 having acompact configuration positionable within the expanded support 110. Theframe 184 can be expanded from the compact configuration to a secondexpanded configuration so as to attach the prosthetic valve 180 to thesupport 110. The frame 184 may be either balloon-expandable, as in thecase of the Sapien valve, or self-expanding, as in the CoreValve valve.

Referring back to FIG. 7A, the expandable support 110 may comprise aninner wall portion 158 configured to inhibit movement of the prostheticvalve 180 relative to the support 110. The inner wall portion 158 maycomprise a covering (not shown), and the covering may have a thicknessand material properties selected so as to provide one or more offriction or compression when an expandable frame 184 (FIG. 7A1) of theprosthetic valve 180 is urged against the inner wall portion 158 of thesupport 110. The covering may be a textile such as Dacron or PTFE, aclosed-cell foam, or a layer of a polymer, ceramic, sintered metal orother suitable material. Alternatively or additionally, the inner wallportion 158 may comprise structures (not shown) to enhance friction orto couple with the frame 184 of the prosthetic valve 180 such as, forexample, bumps, hooks, detents, ridges, scales, protuberances, orcoatings.

In various embodiments, the expandable support 110 will be configured toresist expansion beyond a predetermined diameter even under theexpansion force of a balloon (not shown) used to expand the prostheticvalve 180. Following expansion of the prosthetic valve 180 within thesupport 110, especially where the prosthetic valve 180 is balloonexpandable, some recoil (radial contraction) of both the frame 184 ofthe prosthetic valve 180 and the support 110 may occur. The support 110may therefore be configured to recoil an amount greater than the recoilof the prosthetic valve 180 so that an adequate radial force ismaintained between the two structures. The expandable support 110 maycomprise skeleton 140 which exerts a radially inwardly directed recoilforce against the expandable frame 184 of valve 180, and the expandableframe 184 may comprise a stent which presses radially outward againstthe skeleton 140. The expandable skeleton 140 can move radially outwardwith the stent-like expandable frame 184 when a balloon 194 is placedwithin a lumen of the expandable frame 184 and inflated. When theballoon is deflated, to the extent either the skeleton 140 or theexpandable frame 184 experience inward recoil, the skeleton 140 will beadapted to recoil more than the frame 184. The skeleton 140 may compriseone or more of a first strut arrangement, a first strut dimension, afirst strut geometry or a first strut material, and the expandable frame184 may comprise one or more of a second strut arrangements, a secondstrut dimension, a second strut arrangement or a second strut materialdifferent from the one or more of the first strut arrangement, the firststrut dimension, the first strut geometry or the first strut material,such that the skeleton 140 is urged radially inward with a recoil forcegreater than a recoil force of the frame 184 when a balloon placedwithin a lumen of the frame 184 is deflated.

FIG. 7B is a top view of a prosthetic heart valve device (such asapparatus 100) having an expanded support 110 with arms 120 and apre-fitted valve structures 185, and showing a separate prosthetic valve180 retained and positioned inside the expanded support 100 and withinthe pre-fitted valve structures 185. The pre-fitted valve 185 can, insome embodiments, be the only valve structure used with the device 100for replacement of a native structure. In other embodiments, and asshown in FIG. 7B, a separate prosthetic valve 180 can be deliveredfollowing implantation (either immediately or concurrently during asingle operation, or at a later time or second operation) of the device100 displacing the pre-fitted valve structure 185 when inserted into andexpanded within the support 110. In some embodiments, the pre-fittedvalve structure 185 can be a temporary valve 185. For example, theleaflets 187 of the pre-fitted valve 185 may be folded downstreamagainst an inner wall 158 of the support 110 and sandwiched orcompressed between the prosthetic valve 180 and the support 110. Theleaflets 187 of the pre-fitted valve 185 comprising selectable materialmay assist in sealing space between the inner wall 158 of the support110 and the prosthetic valve 180 to inhibit perivalvular leaks. Inaddition, the pre-fitted valve 185 may enhance compression and/orfriction against an outer surface of the prosthetic valve 180. Thesupport 110 may comprise retaining structures on the inner wall 158configured to couple the prosthetic valve 180 to the support 110 whenthe prosthetic valve 180 has been expanded. The prosthetic valve 180 maycomprise an expandable frame 184 (shown in FIG. 7A1) and retainingstructures on the inner wall 158 of the support 110 may couple to anouter portion of the expandable frame 184 as described above inconnection with FIG. 7A. The retaining structures on the inner wall 158of the support 110 may also urge the pre-fitted valve 185 componentsagainst the expandable frame 184. In some arrangements, the use of theexpandable support 110 of the present technology may allow acatheter-delivered replacement valve 180 of a given size to be implantedin a substantially larger native valve annulus with effective fixationand prevention of perivalvular leaks.

FIGS. 7B1 to 7B3 show components and construction of a temporary valve185 comprising leaflets 187 in accordance with embodiments of thepresent technology. The temporary valve 185 may comprise a sheet ofmaterial 189 such as PTFE, woven or knit polyester, bovine pericardium,porcine valve tissue, or other suitable material. The sheet of material189 can be folded in half and stitched with ePTFE sutures so as to forma cylinder 159 with 3 inner pockets. The inner walls of the threepockets are folded toward the center of the cylinder 159 to as to apposeone another, thus forming the leaflets 187 of the temporary valve 185.The temporary valve 185 can be attached to both ends of the skeleton 140with polypropylene and ePTFE sutures, for example.

FIG. 7C is a top view of a prosthetic heart valve device having anexpandable support with a plurality of arms and a pre-fitted valve 185mounted within the expandable support 110. In some embodiments, thepre-fitted valve 185 can be a permanent valve structure configured foruse with the apparatus 100; however, in other embodiments, thepre-fitted valve 185 can be a temporary valve 185. The outer wall 159(e.g., cylinder shown in FIGS. 7B1-7B3) of the temporary valve 185 canbe configured to coupled to the inner wall 158 of the support 110 withthe leaflets 187 extending across the interior of the support 110 so asto block blood flow through the valve 185 in the upstream direction. Thesupport 110 may include features such as loops, eyelets, cleats, oropenings to which sutures or other suitable fastening means may becoupled to facilitate attachment of temporary valve 185 to the innerwall 185.

The temporary valve 185 can be configured to receive a separatecatheter-delivered prosthetic valve 180 such that the prosthetic valve180 substantially displaces leaflets 187 of the first valve 185 when theprosthetic valve 180 is coupled to the support 110. The temporary valve185 may comprise one or more leaflets 187 adapted so as to increase oneor more of compression or friction with the prosthetic valve 180 when anexpandable frame 184 of the prosthetic valve 180 is urged against theone or more leaflets 187. The support 110 may comprises a covering overits inner wall 158, and the covering may have a thickness sufficient soas to provide one or more of friction or compression when an expandableframe 184 of the prosthetic valve 180 is expanded within the support110. The one or more leaflets 187 of temporary valve 185 can also beadapted to increase compression or the friction with the prostheticvalve 180 when sandwiched between the support 110 and the expandableframe 184 of the prosthetic valve 180.

In alternative embodiments, a temporary valve 185 mounted within thesupport 110 may be configured to be removed prior to coupling apermanent prosthetic valve 180 to the support 110. The temporary valve185 may be mounted within support 110 by detachable couplings, forexample perforated regions of the leaflets 187 that allow the leaflets187 to be torn away easily. Alternatively, the leaflets 187 may becoupled to the support by sutures or other fasteners that can be cutwith catheter-delivered cutting tools. The temporary valve 185 may alsobe made of a bioerodable material configured to erode and dissolve intothe blood over a period of 2 hours to 2 months following implantation.

Instead of a temporary valve 185, a permanent valve may be attached tosupport 110 and implanted therewith. The permanent valve may beconstructed similarly to temporary valve 185 as described above, or likeany of the commercially available percutaneous heart valves. In anycase, the permanent valve will be collapsible so as to have a profilesuitable for percutaneous delivery, and expandable with support 110 forimplantation at the native heart location.

FIGS. 8A-8C are enlarged cross-sectional views of a delivery catheter200 comprising an inner shaft 204, a tubular middle shaft 206 slidableover the inner shaft 204 and a sheath 20 configured to slide over themiddle shaft 206 in accordance with embodiments of the presenttechnology. An inflatable balloon 208 is mounted to a distal end of theinner shaft 204, and the apparatus 100 is removal by mounted over theballoon 208. The inner shaft 204 has an inflation lumen 209 in fluidcommunication with the interior of balloon 208 to allow the delivery ofinflation fluid to the balloon 208 during deployment. The inner shaft204 optionally has a guidewire lumen 210 which extends through balloon208 to a tip 214 through a guidewire GW may be received. In the deliveryconfiguration shown in FIG. 8A, and when sheath 20 is retracted as shownin FIG. 8B, the middle shaft 206 engages the proximal end of the support110 to maintain its position on the balloon 208. In the expandedconfiguration shown in FIG. 8C, the middle shaft 206 slides proximallyrelative to balloon 208 to accommodate the proximal taper of balloon 208when it is inflated. Optionally, the middle shaft 206 may have one ormore longitudinal perforations near its distal end to allow a distalportion of it to split longitudinally as the balloon inflates, thusobviating the need to retract the middle shaft 206 prior to inflation.

In the delivery configuration shown in FIG. 8A, the sheath 20 extendsover the arms 120 so as to constrain them in the inward configuration.When the sheath 20 is retracted as shown in FIG. 8B, the arms 120resiliently move into their unbiased outward configuration, creating agap 212 between the arms 120 and the support 110 in which the nativevalve leaflets may be received by retracting the entire deliverycatheter 200 in the proximal direction (e.g., upstream direction basedon delivery catheter system shown in FIGS. 8A-8C). In operation, oncethe apparatus 100 is located in the desired position (not shown)relative to the native leaflets, preferably with arms 120 engaging thenative annulus in the subannulus space, the balloon 208 may be inflatedas shown in FIG. 2C. Inflation of the balloon 208 expands the support110 to a larger diameter, urging the outer surface of support 110against the annulus. The outer surface 110S of the support 110 expandstoward arms 120, closing or narrowing the gap 212 at least partially. Bynarrowing the gap 212, the arms 120 compresses the native leafletsbetween the support 110 and the arms 120. In addition, it may be notedthat the balloon 208 extends distally beyond the downstream end 114 a ofthe support 110 such that the balloon engages the inwardly curved camregions 126C of arms 120 as it inflates. As the cam regions 126C arepushed outwardly, the tip portions 122 move inwardly toward the support110, further compressing the leaflets.

FIGS. 9A-9D and enlarged cross-sectional views of additional embodimentsof a delivery catheter 200 having an inner shaft 204 and a middle shaft208 similar to those described above in connection with FIGS. 8A-8C. InFIGS. 9A-9B, however, the balloon 208 is axially shorter than balloondescribed in the embodiment shown in FIGS. 8A-8C. The balloon 208 shownin FIGS. 9A-9D is sized to inflate and expand the support 110 withoutextending substantially beyond the upstream or downstream ends 112 a,114 a of the support 110. Intermediate elbow portions 126 of the arms120 may extend distally of the balloon 208 and need not have theinwardly curved cam regions 126C. In this embodiment, the sheath 20 canhave a flange 220 around its distal end. Both the distal and proximalsurfaces of flange 220 can be tapered or rounded inwardly and can beconstructed of or coated with a low-friction lubricious material.

Operatively, in the delivery configuration as shown in FIG. 9A, the arms120 are constrained by the sheath 20 in the inward configuration withthe distal tips 122 against the outer surface of support 110. When thesheath 20 is retracted as shown in FIG. 9B, the arms 120 can resilientlymove outwardly a small amount to an unbiased configuration in which asmall gap 222 is created between the arms 120 and the support 110. Inthis configuration, the arms 120 can be angled outwardly substantiallyless than in the embodiment shown in FIGS. 8A-8C, and, for example, thegap 222 can be less than the gap 212 shown in FIG. 8B. The gap 222 neednot be large enough to receive the native leaflets, needing only to belarge enough to allow flange 220 to be inserted between arms 120 and thesupport 110. As shown in FIG. 9C, the sheath 20 may then be advanceddistally relative to the inner shaft 204 and the apparatus 100 such thatthe flange 220, facilitated by its tapered distal surface, slidesbetween arms 120 and support 110. As the sheath 20 continues to movedistally, the flange 220 is wedged against the inner surfaces of thearms 120, deflecting the arms further outwardly. Preferably, the sheath20 is advanced until the flange 220 is disposed within or near thecurved elbow portions 126 distal to the downstream end 114 a of thesupport 110 so as to provide the maximum area (e.g., gap 222 shown inFIG. 9C) between the arms 120 and the support 110 to receive the nativeleaflets.

The delivery catheter 200 may then be moved proximally (upstream in theillustrated FIGS. 9A-9D) relative to the native valve such that thenative leaflets are received in the now enlarged gap 222 and distal tipportions 122 of the arms 120 engage the annulus. The sheath 20 can thenbe retracted relative to the apparatus 100 and the lubricious, taperedproximal surface of the flange 220 can slide easily over the nativeleaflets without drawing the leaflets out of the gap 222. The arms 120then return to their unbiased configuration of FIG. 9B, closer to theouter surface of support 110. The sheath 20 can then be fully retractedto expose the full length of the support 110, and the balloon 208 can beinflated to expand the support 110 into its expanded configuration, asshown in FIG. 9D. In this step, the gap 222 has closed substantially,with arm tip portions 122 close to or against the outer surface ofsupport 110, thus compressing the native leaflets between the arms 120and the outer surface of the support 110.

FIG. 10 is an enlarged cross-sectional view of a delivery catheter 200that includes a second sheath 226 slidably disposed within a firstsheath 20, in which the second sheath 226 is configured to slide betweenthe outer surface of a support 110 and a plurality of arms 120 of aprosthetic heart valve device (such as apparatus 100) in accordance witha further embodiment of the present technology. In operation, the distalend of the second sheath 226 can engage the inner surfaces of the arms120 in a manner similar to the flange 220 described above with respectto FIGS. 9A-9D. Accordingly, the second sheath 226 can force the arms120, when unconstrained (e.g., with first sheath 20 is retractedproximally), into an outward configuration adapted to receive the nativevalve leaflets. Optionally, the distal end of the second sheath 226 mayhave an enlarged flange similar to flange 220 described with respect toFIGS. 9A-9D, and/or a tapered distal end to facilitate insertion underthe arms 120. In the delivery configuration, sheath 20 covers theapparatus 100 and constrains the arms 120 in an inward configurationnear the outer surface of support 110. In this configuration, the secondsheath 226 may be either retracted within sheath 20 proximal to theapparatus 100 or may be positioned between the support 110 and the arms120. When the sheath 20 is retracted, the second sheath 226 may beadvanced distally until it engages the inner surfaces of the arms 120 inthe area of the curved elbow portions 126. The arms 120 are therebyforced outwardly (not shown) so that the native leaflets can be receivedbetween the arms 120 and the support 110. When the apparatus 100 ispositioned in the desired location (not shown), the second sheath 226can be retracted, allowing the arms 120 to resiliently return to anunbiased configuration closer to the support 110, thereby compressing orretaining the leaflets between the arms 120 and the outside surface ofthe support 110. The balloon 208 can then be inflated to expand thesupport 110 within the native annulus, further compressing the leafletsbetween arms 120 and the outer surface of support 110.

FIGS. 11A-11C are side cross-sectional views of a distal portion of adelivery system for a prosthetic heart valve device (such as apparatus100) configured in accordance with another embodiment of the presenttechnology. As shown in FIGS. 11A-11C, the sheath 20 may have a coaxialconstruction including an inner shaft 228, a coaxial outer shaft 230defining an inflation lumen 232, and a balloon 234 mounted to a distalend of the outer shaft 230. Delivery of an inflation fluid such assaline or contrast fluid through inflation lumen 232 inflates theballoon 234. The apparatus 100 may be positioned within the inner shaft228. In an unbiased condition, the arms 120 are positioned inwardly nearthe outer surface of support 110. Operatively, when the sheath 20 isretracted, the arms 120 can spring slightly outwardly from the support110 a sufficient distance to allow the balloon 234 to be insertedbetween the arm 120 and the support 110 (e.g., by moving the sheath 20distally), as shown in FIG. 11B. The sheath 20 can be advanced distallyuntil the balloon 234 is positioned near the U-shaped elbow portion 126.The balloon 234 may then be inflated and urge arms 120 outwardly asshown in FIG. 11C. The delivery catheter 200 is then retractedproximally relative to the native valve in order to capture the leafletsbetween the arms 120 and the support 110. When the desired location isreached, the balloon 234 may be deflated and the sheath 20 retracted towithdraw the balloon 234 from its position between the support 110 andthe arm 120. The arms 120 may then return to their unbiasedconfiguration closer to the outer surface of the support 110, trappingor retaining the native leaflets between the arms 120 and the support110. In some embodiments, the balloon 234 may be coated with alubricious material in order to facilitate withdrawal of the balloon134, from between the arms 120 and the support 110 without disturbingthe engagement of the leaflets. The support 110 can then be expanded asdescribed above and the apparatus 100 deployed at the native valve site.

FIGS. 12A-12C are side elevational views of various components of adelivery system 300 for a prosthetic heart valve device (such asapparatus 100) configured in accordance with additional embodiments ofthe present technology, and FIGS. 12D-12G are side views of a distalportion of the delivery system of FIGS. 12A-12C. The system 300 caninclude a delivery catheter 200 including a tubular inner sheath 238having a pair of windows 240 on opposing lateral sides near a distal end241. Within the inner sheath 238 a pair of scoops 242, optionallyinterconnected by a ring 243 (shown in FIGS. 12B and 12C) large enoughto slide over support (not shown), are received and axially slidablethrough windows 240 as shown in FIG. 12B. Elongate extensions 244 extendproximally from the ring 243 to facilitate axial movement of the scoops242. The scoops 242 are preformed to be curved positioned with concaveportions facing outward, and with the distal ends 246 spaced furtherapart from the proximal ends 247, as shown in FIG. 12B. The scoops 242may also be curved about a longitudinal axis so as to form a concavespoon-like or trough-like shape, with concavity facing outward. Thescoops 242 may also have a notch 245 cut in their distal ends 246 asshown in FIG. 2C. In some embodiments, the notch 145 can retain the arms120 together as the scoops 242 slide forward (further described below).

Referring to FIG. 12D, the support 110 can be positioned within theinner sheath 238 with arms 120 disposed outside of the inner sheath 238and projecting proximally across the windows 240. In an unbiasedcondition, the arms 120 are configured to naturally reside in a positionclose to the outer surface of support 110. Referring to FIG. 12D, in aninitial configuration for delivery to the target site, the outer sheath20 is slidably disposed over the inner sheath 238 and the arms 120,holding the arms 120 against the exterior of the inner sheath 238.

Once the delivery catheter 200 is at the largest site, the outer sheath20 can be retracted as shown in FIG. 12E to expose the arms 120,allowing the arms 120 to spring outwardly from the support 110 and/orinner sheath 238 to their unbiased configuration, shown in FIG. 12F. Thescoops 242 are then pushed forward relative to the inner sheath 238 andsupport 110, and/or the inner sheath 238 and support 110 are retractedrelative to the scoops 242, such that the scoops 242 move toward theU-shaped elbow portion 126 of the arms 120. Due to theiroutwardly-curved configuration, the scoops 242 urge the arms 120 furtheroutward to create a larger gap 248 between the arms 120 and the innersheath 238, as shown in FIG. 2G. The delivery catheter 200 may then beretracted relative to the native valve, capturing the leaflets betweenthe arms 120 and the inner sheath 238 (not shown). The scoops 242 canthen be retracted back through windows 240 (not shown), exiting thespace between the native leaflets and the inner sheath 238. This allowsthe arms 120 to return to an inward configuration closer to the outersurface of support 110, thereby trapping the leaflets between the arms120 and the support 110. The apparatus 100 may then be expanded anddeployed from the delivery catheter 200 as described in connection withother embodiments.

In some embodiments, the apparatus 100 may have an active mechanism forurging the arms 120 inwardly toward support 110 to more forcefullycompress the leaflets between the arms 120 and the support 110. FIGS.13A-13B are elevated side and oblique views, respectively, of aprosthetic heart device (apparatus 100) having a belt 250 coupledbetween an expandable support 110 and a plurality of arms 120 inaccordance with an embodiment of the present technology. FIGS. 13C and13D are top views of the device 100 shown in FIGS. 13A-13B showing thearms 120 in an outward configuration 123 (FIG. 13C) and in an inwardconfiguration 121 (FIG. 13D). In one embodiment, the belt 250 can becoupled to the support 110 and pass slidably through an eyelet 252 ineach arm 120. The belt 250 may comprise a suture, wire, band, cable, orother flexible element known in the art. Ultra-high molecular weightpolyethylene or stainless steel wire rope can be used in someembodiments because of their strength and creep resistance, which arequalities useful to withstand pulsatile loading and to maintain clampingof the leaflets between the arms 120 and the support 110. In oneembodiment, the belt 250 can be coupled to the support 110 at anchorpoints 254, for example, on opposite sides of the support 110 in thespace between the rows (if present) of arms 120, which, in someembodiments can correspond to locations of the native valve commissures.In some arrangements, anchor points 254 can be located near thedownstream end 114 a of the support 110 so that the belt 250 will notinterfere with the positioning of the native leaflets between the arms120 and the support 110. In some embodiments the eyelets 252 can bemounted to an upstream portion of the arms 120, closer to tip portions122 than to elbow portions 126, so as to maximize leverage of the arms120. Initially, with the support 110 in the radially collapsed deliveryconfiguration, the belt 250 is loose enough to allow arms 120 to resideor rest in their outward configuration 123, shown in FIGS. 13A-C. As thesupport 110 is expanded, the distance D between the opposing anchorpoints 254 is increased, which can cause the belt 250 to tighten,thereby drawing arms 120 inwardly toward the outer surface of thesupport 110, as shown in FIG. 13D.

In an alternative configuration, shown in FIG. 14, a pair of belts(shown individually as 250A and 250B) can be used to actively engage thearms 120. For example, rather than a single continuous belt 250extending around the entire circumference of the support 110 and coupledto all of arms 120 as shown in FIGS. 13-D, one belt 250A can passthrough a first set of arms 120 on one side of the support 110, and asecond belt 250B can pass through a second set of arms 120 on theopposing side of support 110. Each belt 250A, 250B is coupled at itsends to an anchor point 254 on the support 110. In some embodiments,belt 250A can be different than belt 250B such that the first set ofarms 120 can be arranged differently during implantation of theapparatus 100 and/or once implanted in the native valve region than thesecond set of arms 120. For example, for devices suitable forimplantation of the native mitral valve region, it can, in someembodiments, be desirable for the arms 120 engaging the anterior leafletAL to be pulled closer to the support 110 to ensure they do not protrudeinto the left ventricular outflow tract. Accordingly, the belt 250A mayhave a different length or tension than the belt 250B.

Belt 250 may be coupled to the arms 120 in various ways. FIGS. 15A-15Care side views of a portion of an individual arm 120 associated with aprosthetic heart valve device (such as apparatus 100) and showingmechanisms for coupling a belt 250 to the arm 120 in accordance withvarious embodiments of the present technology. As shown in FIG. 15A, thearm 120 has a loop or eyelet 252 mounted on the arms 120 and throughwhich the belt 250 can slidably pass. As shown in FIG. 15B, the arm 120can have a dent, trough, or groove 256 adapted to receive the belt 250and prevent it from slipping down the arm 120 in the downstreamdirection when the belt 250 is tensioned. Alternatively, and as shown inFIG. 15C, the belt 250 can be wrapped around the arm 120 to form acomplete turn or loop 257 such that the belt 250 can slide relative tothe arm 120 while exerting sufficient friction with the arm 120 toinhibit it from sliding along the arm 120. In other embodiments, eyelets252 or other belt-retaining features may be incorporated into the tipportions 122 of the arms 120. For example, the tip portions 122 may forma loop as described elsewhere herein, and the belt 250 may pass throughthe loops.

In a further embodiment, the arm 120 may have a hole, eyelet or otherfeature integrally formed in the arm itself through which the belt 250may pass. FIGS. 16A-16C are oblique views showing the making of an arm120 for a prosthetic heart valve device (such as apparatus 100) whereinthe arm 120 has an eyelet to receive a belt 250 and configured inaccordance with further embodiments of the present technology. Forexample, as shown in FIG. 16A, the arms 120 may each be laser cut from ametal tube 258 so as to have a tab 260 extending from the side of thearm 120. Referring to FIG. 16B, the tab 260 may have a hole 262 throughwhich the belt 250 (not shown) may pass. After laser cutting, the tabs260 may optionally be formed or bent so as to protrude radially outwardfrom the arm 120 such that the hole 262 extends in the circumferentialor tangential direction and is radially outward from the outer surfaceof the arm 120, thereby allowing the belt 250 to slide easily (shown inFIG. 16B). Alternatively, the arm 120 may be twisted, as shown in FIG.16C, to position the tab 260 and the hole 262 in the desiredorientation.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of thetechnology, as those skilled in the relevant art will recognize. Forexample, while steps are presented in a given order, alternativeembodiments may perform steps in a different order. The variousembodiments described herein may also be combined to provide furtherembodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

We claim:
 1. A prosthetic heart valve device for treating a native heartvalve having a native annulus and native leaflets, comprising: anexpandable frame comprising a first portion having a downstream regionand an upstream region and a second portion extending outwardly from thedownstream region of the first portion in an upstream direction when theframe is in an expanded configuration; a valve member attached to aninterior of the first portion; and a skirt coupled to the downstreamregion of the first portion and flaring outwardly in the upstreamdirection separate from the second portion such that an upstream regionof the skirt is spaced outwardly from the first portion and inwardlyfrom the second portion, wherein the skirt extends around the entirecircumference of the first portion.
 2. The device claim 1, wherein thevalve member comprises a tri-leaflet assembly configured to allow bloodflow in the downstream direction and to block blood flow in the upstreamdirection.
 3. The device of claim 1, wherein the valve member comprisesa bi-leaflet assembly configured to allow blood flow in the downstreamdirection and to block blood flow in the upstream direction.
 4. Thedevice of claim 1, wherein the first portion of the frame iscylindrical.
 5. The device of claim 1, wherein the second portion of theframe comprises elongated members extending outwardly from thedownstream region of the first portion of the frame in an upstreamdirection when the frame is in an expanded configuration.
 6. The deviceof claim 5, wherein the elongated members have a covering.
 7. The deviceclaim 1, wherein the frame is configured to receive native heart valveleaflets between the first and second portions of the frame when theframe is in an expanded configuration.
 8. The device claim 1, whereinthe frame further comprise a third portion extending outwardly from theupstream region of the first portion in a downstream direction when theframe is in an expanded configuration.
 9. The device claim 1, whereinthe frame further comprises elongated members extending outwardly fromthe upstream region of the first portion in a downstream direction whenthe frame is in an expanded configuration.
 10. The device of claim 1,wherein the second portion of the frame is biased outwardly from thefirst portion of the frame.
 11. The device of claim 1, wherein the frameis expandable from a low-profile configuration for delivery to anexpanded configuration for implantation at the native heart valve. 12.The device of claim 1, wherein the skirt is configured to inhibit bloodflow between the prosthetic heart valve device and the native heartvalve upon implantation of the prosthetic heart valve device at thenative heart valve.
 13. The device of claim 1, wherein at least aportion of the frame comprises a covering.
 14. The device of claim 1,wherein the first portion of the frame has a circular cross-section. 15.The device of claim 1, wherein the frame is self-expandable.
 16. Aprosthetic heart valve device for treating a native heart valve having anative annulus and native leaflets, comprising: an expandable framecomprising a first portion having a downstream region, an upstreamregion and a circular cross-section, a second portion extendingoutwardly from the downstream region of the first portion in an upstreamdirection when the frame is in an expanded configuration, and a thirdportion extending outwardly from the upstream region of the firstportion in a downstream direction when the frame is in an expandedconfiguration; a valve member attached to the first portion; and a skirtcoupled to the downstream region of the first portion and flaringoutwardly in the upstream direction separate from the second portionsuch that an upstream region of the skirt is spaced outwardly from thefirst portion and inwardly from the second portion, wherein the skirtextends around the entire circumference of the first portion, andwherein the frame is configured to receive native heart valve leafletsbetween the first and second portions of the frame when the frame is inan expanded configuration.
 17. A prosthetic heart valve device fortreating a native heart valve having a native annulus and nativeleaflets, comprising: an expandable frame comprising a valve supporthaving a downstream portion and an upstream portion, a plurality of armscoupled to the downstream portion of the valve support, wherein the armsextend outwardly from the support in an upstream direction when theframe is in an expanded configuration; a valve member attached to thevalve support; and a skirt coupled to the downstream portion of thevalve support and extending outwardly in the upstream direction separatefrom the arms such that an upstream portion of the skirt is spacedoutwardly from the valve support and inwardly from the arms, wherein theskirt extends around the entire circumference of the valve support, andwherein the frame is configured to receive native heart valve leafletsbetween the valve support and the arms when the frame is in an expandedconfiguration.
 18. The device of claim 17, wherein the arms comprise acovering.
 19. The device of claim 17, wherein the frame furthercomprises a plurality of elongated members extending outwardly from theupstream portion of the valve support in a downstream direction when theframe is in an expanded configuration.
 20. The device of claim 17,wherein the skirt is configured to inhibit blood flow between the valvesupport and the native heart valve upon implantation of the prostheticheart valve device at the native heart valve.